Qureos Mentor

PCI Pharma Services

<div><div>Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.</div><div><br>
We are PCI.</div><div><br>
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.</div><div></div><div><br>
Summary:<br>
Under minimal supervision, the Validation Associate III performs complex validation and qualification activities for critical equipment, utilities, and processes used in Drug Product Manufacturing, Quality Control Chemistry, and Microbiology.<br>
<br>
Essential Duties and Responsibilities:</div><ul><li>
Validation documentation author for equipment, systems and utilities leveraging novel and complex validation strategies (Validation Protocol and Report Generation).</li><li>
Performance of Validation (IQ/OQ/PQ) and routine Requalification activities, coordinating with process owners and support teams within projects to prioritize adherence to critical timelines.</li><li>
Experience supporting cross-functional development of user requirement specification (URS), familiarity with Functional Specifications (FS) and Design Specifications (DS).</li><li>
Ability to execute demanding physical Validation activities, following protocols and/or procedures, and documenting results on controlled forms in real time with adherence to GDP procedures.</li><li>
Experience with Kaye Validator AVS and temperature mapping preferred.</li><li>
Deviation investigation, technical writing and ability to independently own quality events (Deviation, CAPA, Change Controls, etc.)</li><li>
Represent Validation department in recurring cross-functional or specific meetings as Validation point of contact.</li><li>
Ownership of assigned projects to meet critical timelines, and escalate challenges to supervisor.</li><li>
Training, database entry, and regulatory / client audit support.</li><li>
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].</li><li>
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company&rsquo;s policies and practices.</li><li>
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.</li></ul><div></div><div>
Qualifications:</div><ul><li>
Bachelor&rsquo;s or Associate degree in Sciences, Engineering, or a similar discipline strongly preferred with a minimum of four (4) years of relevant experience</li><li>
Minimum of two (2) years of experience supporting GMP operations or similar.</li><li>
Strong understanding of GMP compliance and regulations</li><li>
Detail oriented with strong written and verbal communication skills</li><li>
Ability to work independently within prescribed guidelines or as a collaborative team member.</li><li>
Experience with Microsoft Office applications</li><li>
Experience with Kaye Validator operation required</li></ul><div></div><div>
The hiring rate for this position is $36.54 - 41.10/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).</div><div>
#LI-AK2</div><div></div><div>
Join us and be part of building the bridge between life changing therapies and patients. <div>Let&rsquo;s talk future</div></div><div></div><div>
Equal Employment Opportunity (EEO) Statement:<br>
<i>PCI Pharma Services is an Equal </i><i>Opportunity/Affirmative</i><i> Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.</i></div><div></div><div><i>
At PCI, Equity and Inclusion are at the core of our company&rsquo;s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity &ndash; at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.</i></div></div><div></div>

Validation Associate III

<div><div>Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.</div><div><br>
We are PCI.</div><div><br>
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.</div><div></div><div><br>
Position Title: Business Development Coordinator</div><div><div>
Location: Fully Remote</div><div></div><div>
SUMMARY OF OBJECTIVE:</div><div><br>
Entry level role to the Business Development Process, responsible for liaising with Business Development Team, supporting senior management, general administration and Salesforce.com data entry.</div><div></div><div>
ESSENTIAL DUTIES AND RESPONSIBILITIES:</div><ul><li><div>
General administration of Salesforce.com.</div></li><li><div>
Global Salesforce.com entry management of Proposals, Revisions to Proposals and Change Orders</div></li><li><div>
Data and report gathering to support Senior Management.</div></li><li><div>
Reporting from salesforce on weekly/monthly/yearly trends across the Clinical Business</div></li><li><div>
Global management of awarded Proposals, Revisions to Proposals and Change Orders.</div></li><li><div>
Knowledge of and adherence to all relevant PCI, cGMP, and GCP policies, procedures, rules.</div></li><li><div>
Attendance to work is an essential function of this position.</div></li><li><div>
Performs other duties as assigned by Manager/Supervisor.</div></li></ul><div></div><div>
QUALIFICATIONS:</div><div>
Required:</div><ul><li><div>
Associate's Degree in a related field and/or 1-3 years related experience and/or training.</div></li><li><div>
College Level Mathematical Skills</div></li><li><div>
Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.</div></li><li><div>
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.</div></li><li><div>
Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.</div></li></ul><div><br>
Preferred:</div><ul><li><div>
Ability to demonstrate attention to detail.</div></li><li><div>
Ability to hold oneself in a professional manner.</div></li><li><div>
Excellent Time management skills.</div></li></ul><div>
#LI-KH1</div></div><div></div><div>
For Illinois residents: the hiring rate for this position is $18.15 to $20.42 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).</div><div></div><div>
Join us and be part of building the bridge between life changing therapies and patients. <div>Let&rsquo;s talk future</div></div><div></div><div>
Equal Employment Opportunity (EEO) Statement:<br>
<i>PCI Pharma Services is an Equal </i><i>Opportunity/Affirmative</i><i> Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.</i></div><div></div><div><i>
At PCI, Equity and Inclusion are at the core of our company&rsquo;s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity &ndash; at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.</i></div></div><div></div>

Clinical Business Development Coordinator

<div>
 Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
 <br/>
 <br/>
 <strong>
  We are PCI.
  <br/>
  <br/>
 </strong>
 Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
 <br/>
 <br/>
 Job Title: Supervisor, Warehouse
 <br/>
 <br/>
 Department/Group: Warehouse
 <br/>
 <br/>
 Location: Philadelphia
 <br/>
 <br/>
 **This position is on site 3rd shift**
 <br/>
 <br/>
 <strong>
  Summary Of Objective
  <br/>
  <br/>
 </strong>
 Supervises and trains the Warehousers and ASRS operators to support plant operations, product shipping, and component receiving to ensure inventory accuracy and timely supply of materials to production rooms to meet customer demands.
 <br/>
 <br/>
 Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
 <br/>
 <br/>
 <ul>
  <li>
   Daily scheduling of warehouse personnel to ensure proper staffing to respond to work demands in a productive, cost effective and timely manner.
  </li>
  <li>
   Direct supervision of the day-to-day activities to ensure that the receiving, storage and distribution of materials is done in an efficient manner.
  </li>
  <li>
   Responsible for warehouse safety programs in order to provide a safe work environment ensuring that safety related procedures are followed, and all equipment is properly functioning and maintained.
  </li>
  <li>
   Responsible for cycle counting and inventory accuracy.
  </li>
  <li>
   Responsible for maintaining a clean Warehouse and investigating problem skids; helps resolve scanning and systems issues.
  </li>
  <li>
   Responsible for maintaining the flow and use of the ASRS and associated input conveyors and out faces.
  </li>
  <li>
   Expedites needed materials for production and shipping.
  </li>
  <li>
   Enforces all warehouse systems processes and procedures.
  </li>
  <li>
   Responsible for training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  </li>
  <li>
   Turns in daily attendance report to HR.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Supervisory Responsibilities
  <br/>
  <br/>
 </strong>
 Warehousers and ASRS Operator
 <br/>
 <br/>
 Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
 <br/>
 <br/>
 The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Must be physically capable of performing the above duties with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.
 <br/>
 <br/>
 Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 <br/>
 <br/>
 The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 <br/>
 <br/>
 The noise level in the work environment is usually moderate.
 <br/>
 <br/>
 Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 <br/>
 <br/>
 <strong>
  Education Or Equivalent
  <br/>
  <br/>
 </strong>
 Associate degree Business/Logistics Management
 <br/>
 <br/>
 <strong>
  Knowledge/Skills Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Strong organizational skills and proven ability to multi-task
  </li>
  <li>
   Excellent communication and interpersonal skills
  </li>
  <li>
   Ability to teach, supervise and mentor.
  </li>
  <li>
   Demonstrated ability to read, write and understand customer specifications, cGMPs and SOPs.
  </li>
  <li>
   COMPUTER SKILLS:
  </li>
  <li>
   Experience with inventory control systems
   <br/>
   <br/>
  </li>
 </ul>
 Join us and be part of building the bridge between life changing therapies and patients. Let&rsquo;s talk future
 <br/>
 <br/>
 <strong>
  Equal Employment Opportunity (EEO) Statement
  <br/>
  <br/>
 </strong>
 <em>
  PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
  <br/>
  <br/>
 </em>
 <em>
  At PCI, Equity and Inclusion are at the core of our company&rsquo;s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity &ndash; at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
  <br/>
  <br/>
 </em>
</div>


Warehouse Supervisor

Join PCI Pharma Services and explore 3   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.

PCI Pharma Services

About Company

Validation Associate III

Clinical Business Development Coordinator

Warehouse Supervisor