Qureos Mentor

INCOG BioPharma Services

INCOG BioPharma Services is a Contract Development and Manufacturing Organization (CDMO) that focuses on supporting injectable drug products. Their services include technical transfer, analytical method development and validation, process scale-up, and the formulation and filling of vials, syringes, and cartridges. Additionally, they provide customized packaging services, which encompass labeling, device assembly, auto-injector assembly, cartoning, final packaging, and integrated storage solutions under various temperature conditions.

<div>Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization&rsquo;s Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps.

The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. 
Essential Job Functions:
<ul><li>
Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor.</li><li>
Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc.</li><li>
Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations.</li><li>
Support other QA personnel with batch record reviews, material release, etc.</li><li>
Prioritize and coordinate his/her time in balancing production timelines with product quality assurances.</li><li>
Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution.</li><li>
Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.</li><li>
Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.</li><li>
Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.</li><li>
Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.</li><li>
Ability to manage multiple projects in a fast-paced environment.</li></ul>

Special Job Requirements:
<ul><li>
This position will support primarily second shift (3 pm to 11:30 pm) with occasional weekend support, dependent on operations&rsquo; needs.</li><li>
Bachelor&rsquo;s Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.)</li><li>
Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment.</li><li>
Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc..</li><li>
Understanding of Good Documentation Practices (GDPs) and its criticality.</li><li>
Excellent written and verbal communication skills.</li><li>
General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).</li></ul>

Additional Preferences:
<ul><li>
Hands-on experience with aseptic manufacturing, inspecting finished products, and Acceptable Quality Limits (AQLs).</li><li>
Experience with Continuous improvement, Six Sigma, and/or Lean principles.</li></ul> 

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

By submitting your resume and details, you are declaring that the information is correct and accurate.</div>

QA Associate, 2nd Shift

<div>Job Description

INCOG BioPharma Services is seeking an experienced and highly motivated Packaging Supervisor to lead third shift operations within the packaging department. This role is responsible for overseeing bulk and automated packaging activities for sterile drug products, ensuring safe, compliant, and efficient execution of all packaging operations. 
The Packaging Supervisor provides direct leadership to Packaging Associates and Team Leads, driving performance to meet production goals while maintaining the highest standards of quality and cGMP compliance. This individual serves as a key operational leader, ensuring alignment with internal teams, client expectations, and regulatory requirements. 
This is a Third Shift Position 
Essential Job Functions:
<ul><li>
Supervise and coordinate third shift packaging operations, including bulk and automated packaging of sterile injectable products.</li><li>
Lead, coach, and develop Packaging Associates and Team Leads to achieve production, quality, and safety objectives.</li><li>
Ensure all packaging activities are executed in compliance with cGMP regulations, SOPs, and company quality systems.</li><li>
Monitor production performance, identify issues, and implement corrective actions to meet or exceed production targets.</li><li>
Review and approve batch records, logbooks, and associated documentation for accuracy and completeness.</li><li>
Oversee line setup, changeovers, and equipment readiness to minimize downtime and maximize efficiency.</li><li>
Partner with Quality, Manufacturing, Maintenance, and Supply Chain teams to resolve operational issues and support continuous improvement initiatives.</li><li>
Escalate and support investigations related to deviations, non-conformances, and equipment failures.</li><li>
Ensure proper in-process inspections and controls are performed to maintain product quality and compliance.</li><li>
Drive continuous improvement efforts related to processes, documentation, and equipment performance.</li><li>
Maintain a safe work environment by enforcing safety procedures and promoting a culture of accountability.</li><li>
Support training initiatives, ensuring all personnel are qualified and compliant with training requirements.</li><li>
Manage shift handoff communications to ensure continuity between operations teams.</li><li>
Ensure cleanliness and sanitization of packaging areas in accordance with established procedures.</li></ul> 
Special Job Requirements:
<ul><li>
Bachelor&rsquo;s degree in a scientific, engineering, or related field preferred; equivalent experience considered.</li><li>
Minimum of 5+ years of GMP pharmaceutical experience in packaging, manufacturing, or related operations.</li><li>
Minimum of 2+ years of leadership or supervisory experience in a regulated environment.</li><li>
Experience with sterile drug product packaging and/or injectable devices strongly preferred.</li><li>
Ability to work overnight/third shift hours and provide leadership support during off-hours operations.</li></ul> 
Additional Preferences:
<ul><li>
Strong knowledge of cGMP regulations and pharmaceutical packaging processes.</li><li>
Proven leadership, coaching, and team development skills.</li><li>
Strong problem-solving and decision-making abilities in a fast-paced environment.</li><li>
Excellent documentation review and technical writing skills.</li><li>
Effective communication and cross-functional collaboration skills.</li><li>
High attention to detail with a focus on quality and compliance.</li><li>
Ability to manage multiple priorities and drive results with minimal oversight.</li><li>
Experience with automated packaging systems and equipment troubleshooting.</li><li>
Continuous improvement mindset with experience in Lean or operational excellence initiatives preferred.</li></ul> 
INCOG&rsquo;s Benefits:
<ul><li>
Paid vacation days, amount based on tenure, and paid sick time</li><li>
11 observed holidays</li><li>
401(k) plan with company match up to 3.5% of salary, vested immediately</li><li>
Choice of health &amp; wellness plans</li><li>
FSA and HSA programs</li><li>
Dental &amp; vision care</li></ul> 
Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. 
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. 
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. 
By submitting your resume and details, you are declaring that the information is correct and accurate.</div>

Packaging Supervisor, 3rd shift

<div>Manufacturing Specialist - Formulation Summary

INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in the formulation of sterile drug products. The Manufacturing Specialist (Formulation) is a key role within INCOG BioPharma Operations. The ideal candidate must have experience in pharmaceuticals and/or biologics formulation. 
 
The primary responsibility of the Manufacturing Specialist in Formulation is to weigh/dispense, setup/operate equipment to produce the bulk drug product for sterile manufacturing. They will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced. The ideal candidate should demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and work effectively with internal partners, clients, and vendors. 
This is a 2nd shift position. Typical hours are 3:00PM-11:30PM Monday-Friday. 

Essential Job Functions:
<ul><li>Follow production and manufacturing procedures.</li></ul>
<ul><li>Perform duties in Grade C, D, and controlled non-classified cleanrooms.</li></ul>
<ul><li>Perform cleaning and sanitization, equipment preparation, and support aseptic filling duties as needed.</li></ul>
<ul><li>Operate formulation equipment including setup and post cleaning.</li></ul>
<ul><li>Accurately document data and complete batch records.</li></ul>
<ul><li>Execute validation/engineering protocols as needed.</li></ul>
<ul><li>Train others in various manufacturing tasks including, but not limited to: formulation/dispensing, sanitization, component and equipment preparation.</li></ul>
<ul><li>Perform routine maintenance and troubleshooting of production equipment.</li></ul>
<ul><li>Support equipment optimization efforts and continuous improvement efforts.</li></ul>
<ul><li>Collaborate and communicate with cross functional teams.</li></ul>
<ul><li>Work flexible hours to ensure production facility coverage.</li></ul> 
Special Job Requirements:
<ul><li>Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic. processing (fill and finish) general Good Manufacturing Practices (cGMP).</li></ul>
<ul><li>1 year of pharmaceutical formulation experience or 3+ years of experience with the operation, cleaning, and maintenance of pharmaceutical filling equipment.</li></ul>
<ul><li>Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required.</li></ul> 
Additional Preferences:
<ul><li>BS in biological sciences/biotechnology or related field.</li></ul>
<ul><li>Excellent communication skills.</li></ul>
<ul><li>Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.</li></ul>
<ul><li>Ability to learn and operate a range of industry systems including and not limited to ERP and inventory management systems.</li></ul> 
Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. 
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. 
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. 
By submitting your resume and details, you are declaring that the information is correct and accurate.</div>

Manufacturing Specialist - Formulation, 2nd shift

<div>
 INCOG BioPharma Services is seeking an experienced and detail-oriented Deviation Writer to join our Manufacturing Engineering team. This role is crucial for translating a variety of complex technical events into clear, accurate, and robust investigations. The Deviation Writer will work closely with the Manufacturing, Production Engineering, Manufacturing Sciences and Technology, Supply Chain, Quality, and other cross-functional teams to create comprehensive investigations that leverage facts and data to support robust root cause conclusions, effective corrective actions, and systematic all-encompassing preventative actions. The Deviation Writer will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments. The Deviation Writer will have strong familiarity with industry standard electronic Quality Management System(s) and Microsoft Office suite products.
 
 
 They will thrive working autonomously utilizing strong self-management and organization skills but also be able to interact, collaborate, and lead within a team environment. The Deviation Writer will value the processes owned by internal customers and subject matter experts and will possess a demonstrated ability to support and influence positive outcomes in the application of that knowledge to wider processes.
 
 
 
 Essential Job Functions:
 
 
 
 <ul>
 <li>
 Understand, investigate, and author a variety of deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts.
 </li>
 <li>
 Self-motivated to fact gather, analyze information, interpret data, utilize expertise from Subject Matter Experts, etc. in an effort to provide supportive evidence to the investigation and root cause.
 </li>
 <li>
 Experience utilizing a variety of analysis tools to support root cause identification; Ishikawa Fishbone, 5 Why, etc.
 </li>
 <li>
 Ability to critically think outside the box for robust corrective and preventative actions; leveraging automation and engineering controls to error-proof equipment and processes.
 </li>
 <li>
 Demonstrated ability to translate complex, technical processes and descriptions into simplified, understandable write ups.
 </li>
 <li>
 Eagerness to collaborate and partner with both internal and external stakeholders to comprehensively represent the facts of an investigation in a logical and presentable manner.
 </li>
 <li>
 Evaluating historical deviating conditions, adverse events, non-conformances, etc. in order to identify and prevent trends.
 
 
 
 </li>
 </ul>
 
 Special Job Requirements:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in a scientific, engineering, or technical discipline.
 </li>
 <li>
 Minimum of 3 years of experience in technical writing within a regulated GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries.
 
 
 
 </li>
 </ul>
 
 Additional Preferences:
 
 
 
 <ul>
 <li>
 Proficient in writing clear, concise, and accurate technical documentation.
 </li>
 <li>
 Strong understanding of GMP manufacturing processes and regulatory requirements.
 </li>
 <li>
 Excellent organizational skills with high attention to detail.
 </li>
 <li>
 Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences.
 </li>
 <li>
 Familiarity with documentation tools and electronic document management systems (EDMS).
 </li>
 <li>
 Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel.
 
 
 
 </li>
 </ul>
 
 Additional info about INCOG BioPharma Services:
 
 
 
 
 At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
 
 
 
 
 If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
 
 
 
 
 INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
 
 
 
 
 By submitting your resume and details, you are declaring that the information is correct and accurate.
 
</div>

Deviation Writer

<div>
 Working closely with the Director of Quality, the Quality Supervisor will serve as an integrated quality leader with accountability spanning both Quality Assurance Operations and Quality Control activities. This role is instrumental in championing INCOG&rsquo;s Quality Mindset and fostering a culture of efficiency, attention to detail, and on-time delivery across manufacturing and laboratory functions.
 
 
 The Supervisor will need to successfully navigate and identify operational and quality gaps in both the manufacturing environment and the QC laboratory setting. They will bring a balanced technical depth across GMP manufacturing oversight, contamination control, and laboratory testing operations &mdash; ensuring seamless alignment between QA and QC functions in support of compliant, inspection-ready operations.
 
 
 The Quality Supervisor will exemplify excellent interpersonal skills and develop productive, customer-centric working relationships with subordinates, colleagues, customers, suppliers, and partners. The Supervisor will demonstrate excellent written and oral communication skills, with the ability to clearly and concisely articulate complex issues to a range of audiences. The Supervisor will thrive in a team environment but will also work autonomously, leveraging strong self-management and organizational skills. They will value process owners and subject matter experts and will possess a demonstrated ability to influence positive outcomes without direct reporting authority.
 
 
 
 Essential Job Functions
 
 
 
 <ul>
 <li>
 This position will support primarily the Weekend Night shift (7 pm to 7:30 am; Friday, Saturday, Sunday), with occasional off-shift support dependent on operations&rsquo; needs.
 </li>
 <li>
 Recruit, build, and lead an integrated QA Operations team; train and maintain an engaged workforce competent in the theory and application of quality processes across aseptic drug product manufacturing.
 </li>
 <li>
 Maintain an on-floor presence to coach, mentor, and enforce rigorous quality work standards; prioritize and coordinate QA resources to balance production timelines with product quality assurances.
 </li>
 <li>
 Lead development of room/line clearance processes for formulation, aseptic filling, and inspection/packaging areas; train QA personnel on gowning requirements, contamination controls, aseptic line operations, and equipment applications and verifications.
 </li>
 <li>
 Lead QA strategy in partnership with Operations for on-floor batch record review and correction; establish an ongoing state of readiness for rapid decision-making in the evaluation of deviating events, product segregation requirements, and implementation of initial corrective actions.
 </li>
 <li>
 Partner with EH&amp;S and Operations management to communicate safety expectations, assess safety behaviors, practice positive intervention, and enforce best practices aligned to SOPs, compliance requirements, and site goals.
 </li>
 <li>
 Provide technical support, oversight, and team leadership for QC Chemistry, Microbiology, and QC Technical Services; oversee daily QC activities to ensure testing and data review is completed within appropriate timeframes.
 </li>
 <li>
 Deliver daily expectations and assignments to QC personnel; provide in-lab support as needed for routine and on-demand testing.
 </li>
 <li>
 Develop QC team members through mentorship to analysts and data reviewers; communicate with Quality Control Leadership on team performance.
 </li>
 <li>
 Support deviation investigations, laboratory investigations, and CAPA implementation spanning both manufacturing and laboratory quality events; develop and improve current processes to maintain and control general QC functions.
 </li>
 <li>
 Conduct laboratory walk-throughs to ensure inspection readiness and cGMP compliance across all QC laboratory operations.
 </li>
 <li>
 Continuously evaluate processes and procedures across QA and QC functions to create a productive environment while maintaining the highest possible quality standards; ensure all work is carried out in accordance with regulatory requirements, cGMP, and SOPs.
 </li>
 <li>
 Influence the accomplishment of company-wide and team goals; inspire team members while consistently modeling ALP values in all interactions.
 
 
 
 </li>
 </ul>
 
 Special Job Requirements
 
 
 
 <ul>
 <li>
 Bachelor's Degree required; Science discipline preferred (Chemistry, Biology, Biochemistry, Microbiology, or related field).
 </li>
 <li>
 Minimum of 5 years of cGMP experience in biopharma or a similarly regulated industry, including at least 2 years in a Quality Assurance capacity.
 </li>
 <li>
 Working knowledge of QC Microbiology and/or Chemistry, GxP principles, CAPA/investigation management, data/document review, and relevant quality and regulatory requirements.
 </li>
 <li>
 Working knowledge of contamination controls, manufacturing processes, and output quality across automated and non-automated systems, including associated data integrity requirements.
 </li>
 <li>
 Demonstrated experience making risk-based decisions to ensure product quality.
 </li>
 <li>
 Knowledge of aseptic techniques and processing.
 </li>
 <li>
 Strong communication and relationship-building skills across all levels of the organization, including operations, quality, and business leadership.
 
 
 
 </li>
 </ul>
 
 Additional Preferences
 
 
 
 <ul>
 <li>
 Advanced Degree.
 </li>
 <li>
 Certification(s) in Risk Management, Quality Process Analysis, Technical Writing, and/or Quality Investigation.
 </li>
 <li>
 Hands-on experience with aseptic manufacturing Quality, including isolator based processing.
 </li>
 <li>
 3 to 5 years of demonstrated working knowledge of GMP laboratory operations (QC Chemistry and/or Microbiology).
 </li>
 <li>
 2+ years of experience as a people leader or supervisor.
 </li>
 <li>
 First-hand experience participating in and/or hosting operational floor inspection tours related to Quality Assurance.
 </li>
 <li>
 Experience building processes and procedures.
 </li>
 <li>
 Experience with Continuous Improvement, Six Sigma, and/or Lean principles.
 
 
 
 </li>
 </ul>
 
 Additional Information About INCOG BioPharma Services
 
 
 
 
 At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
 
 
 
 
 If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
 
 
 
 
 INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
 
 
 
 
 By submitting your resume and details, you are declaring that the information is correct and accurate.
 
</div>

Quality Supervisor, Weekend Night Shift