Sr. QA Associate I

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

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.

The Sr. QA Associate I is a Quality Subject Matter Expert whom ensures manufacturing areas are maintained in strict compliance. Independently reviews and approves lot file documentation. Identifies and assesses regulatory and quality risks in manufacturing activities and processes. Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis. Drives process improvements and enhancements. Leads projects and trains junior staff. Provides quality expertise and guidance to operational staff.
 

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.

• Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas

• Independently reviews and approves production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices.

• Independently performs quality operations within multiple manufacturing departments

• Participates in multiple process improvement projects

• Develop, revise, review and approve controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and tech transfer forms

• Reviews and approves executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product. Represents QA for high profile clients

• Provides quality oversight of quality reports including deviations, corrective and preventive actions (CAPAs) and risk management plan (RMP)

• Provides quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions

• Supports the Facility/Equipment/Process Change Control System including developing recommendations for change tasks, managing timelines, and performing follow-ups to evaluate the effectiveness of changes.

• Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.

• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].

• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

• Embodies PCI Pharma Services’ cultural values and aligns daily actions with department goals and company culture

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.

Required:

• High school diploma or equivalent required. Bachelor’s degree preferred in a Life Sciences discipline or equivalent relevant experience required.

• Minimum of four to six (4-6) years of experience in documentation, QA, Manufacturing, technical quality, validation, or equivalent.

• Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity.

• Knowledge of Fill Finish and Biologics production environments preferred.

• Familiarity working with electronic batch records.

• Detail oriented and strong interpersonal and verbal communication skills.

Physical Demands:

• constantly required to sit, and to reach to use computers and other office equipment

• constantly stand for extended periods of time, up to four (4) hours/time.

• frequently required to lift up to 40 pounds

• constantly required to view objects at close and distant ranges with hand and eye coordination

• frequently required to communicate with others

#LI-KC1
*The hiring rate for this position is $36.54 - $41.11 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), a flexible spending account, and a 401(k) plan.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
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.

At PCI, Equity and Inclusion are at the core of our company’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 – 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.