Qureos Mentor

Binding Minds, LLP

Qualifications<ul><li>Associate&rsquo;s degree or equivalent advanced education or training.</li><li>Strong knowledge of manufacturing operations, quality, and supplier quality management (preferred).</li><li>Experience with SAP, TrackWise, and Veeva QualityDocs (preferred).</li><li>Experience in Change Management.</li><li>High proficiency with MS Office (Teams, OneNote, OneDrive, SharePoint, PowerPoint, Excel).</li><li>Proven ability to communicate and deliver constructive feedback, with strong interpersonal, oral presentation, and written communication skills.</li><li>Demonstrated creativity in strategy development and problem solving.</li><li>Ability to work both independently and collaboratively with minimal supervision.</li><li>Ability to communicate, influence, and train effectively.</li></ul>Additional Skills/Preferences<ul><li>Minimum of five (5) years of experience at a manufacturing site within a QA organization.</li><li>Strong knowledge of quality management, supplier quality management, ISO, and GMPs.</li><li>Experience with PowerApps, Power BI, Tableau.</li><li>Familiarity with GQS, CQP, LQP.</li><li>Proficient English oral and written communication.</li><li>Ability to travel to manufacturing sites as required.</li></ul>ResponsibilitiesThe Quality Control Representative is responsible for executing the Global Supplier Quality Management (GSQM) Program in support of new site expansions. The role ensures effective and timely onboarding of suppliers, materials, and GMP service providers to support supply chain and affiliate project timelines. This position partners closely with cross-functional business teams to ensure consistent implementation across networks and functions.The GSQM program promotes a globally consistent and holistic approach to GMP supplier and GMP service provider management, ensuring strong compliance, patient safety, product quality, and robust technical standards.Key Objectives / DeliverablesActivities will be performed according to established procedures, guidelines, forms, and tools. Responsibilities include, but are not limited to:<ul><li>Execute supplier quality management processes in accordance with Global Quality Standards (GQS305, GQS301, GQS307, and others as applicable).</li><li>Support procurement, supply chain, GQAAC, MMQA, TS/MS, and manufacturing teams in identifying and managing material suppliers and GMP service providers.</li><li>Perform SAP and TW138 activities related to the Approved Supplier List (ASL) on behalf of site expansions; collaborate with SAP Business QA as needed.</li><li>Coordinate with manufacturing and affiliate sites across the network (API, Manufacturing, Packaging, DPEM, APIEM, Devices) to ensure robust and effective process execution, escalating barriers where necessary.</li><li>Develop and communicate processes associated with the GSQM program and related initiatives.</li><li>Support the maintenance of supplier quality management data, including approved supplier and GMP service provider lists, in systems such as SAP, VeevaVault (QDocs), and TrackWise.</li><li>Assist with Certification Package Review Boards and global certification packages for SAP Manufacturing Plants (MPs) materials.</li><li>Collaborate with Global TS/MS to execute material risk control strategies, including material risk, product acceptance risk, and specification controls.</li><li>Provide input and support for supplier-related change controls.</li></ul>This role requires maintaining comprehensive knowledge of applicable regulations, technical requirements, and training to fulfill these responsibilities.Personal Development<ul><li>Stay current on industry trends and regulatory interpretations of GMP/cGMP requirements, especially those related to Supplier Management Programs.</li><li>Maintain strong interpersonal, verbal, and technical writing skills.</li><li>Complete required training and qualifications outlined in the Learning Plan (LP).</li></ul>Comments / Special Instructions This is an onsite position.Job Type: ContractPay: $36.00 - $38.35 per hourWork Location: In person

Quality Control Representative

Qualifications:<ul><li>B.S./M.S. in life sciences (biology, neuroscience, or related field) or 2+ years of experience in the pharmaceutical industry or a contract research organization</li><li>Passion, knowledge, and experience in neuroscience or rare disease research</li><li>Hands-on experience with rodent handling and dosing, including subcutaneous (SC), intravenous (IV), and intraperitoneal (IP) administration</li><li>Experience with small animal stereotaxic surgeries (e.g., intracerebral [IC], intracisterna magna [ICM], intracerebroventricular [ICV] injections) is a plus</li><li>Experience performing gross necropsies, tissue dissection, trimming and processing, and collection of bodily fluids (blood, cerebrospinal fluid [CSF])</li><li>Ability to adapt to changing platform needs, workflows, and project requirements</li><li>Ability to design, execute, analyze, and interpret experiments independently to advance scientific understanding</li><li>Strong communication skills and effectiveness in cross-functional collaboration</li><li>Strong organizational skills, attention to detail, critical thinking, and the ability to multitask in a fast-paced environment</li><li>Experience processing, organizing, analyzing, and visualizing data from varied sources, with the ability to extract meaningful insights</li></ul>Responsibilities: The in vivo pharmacology Biologist will support the Gene Therapy in vivo pharmacology lab by executing studies related to the discovery and optimization of novel therapeutic candidates for genetic medicines.<ul><li>Partner with team leads to design and execute in vivo pharmacology experiments assessing activity, distribution, and clearance of genetic medicines in rodent models, including immunocompromised animals</li><li>Assist in developing and characterizing novel in vivo models</li><li>Collaborate with cross-functional teams (Preclinical, Toxicology, PK/PD Modeling) to support translation from discovery to development</li><li>Prepare and deliver written and verbal summaries of experimental work in study reports and team meetings</li><li>Maintain accurate, timely documentation of all laboratory work in electronic notebooks in compliance with quality standards and Good Documentation Practices</li><li>Ensure adherence to all applicable health and safety regulations.</li></ul>Pay: $40.00 - $45.00 per hourExpected hours: 40.0 per weekApplication Question(s):<ul><li>Do you have experience performing small animal stereotaxic surgeries?</li><li>Do you have experience in in vivo pharmacology?</li></ul>Work Location: In person

Biologist

Join Binding Minds, LLP and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Binding Minds, LLP

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Quality Control Representative

Biologist