QA Group Lead - Second Shift

SUMMARY

The QA Group Lead is responsible for performing a wide variety of semi‑routine, moderate to highly complex activities pertaining to assuring compliance with applicable regulatory requirements, providing QA oversight of manufacturing operations, documentation and record management, facility and equipment management, change controls, investigations, and support of validation activities. Responsible for coordination and coaching of junior QA staff to resolve issues and ensure compliance with applicable regulations and client requirements.

• Leads the review and approval of executed technical documentation in support of the manufacture and testing of Drug Substance and Drug product.
• Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
• Coordinates and schedules quality functions to support cGMP processes.
• Supports cGMP activities by providing oversight, guidance, and quality decision making.
• Communicates shift team status to other team leaders within QA and other cross‑functional departments as needed.
• Monitors and communicates team metrics.
• Coaches cross‑functional team members to ensure compliance with internal documents and applicable regulations.
• Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis.
• Performs review of production records and associated data to ensure compliance. May be responsible for batch approval/rejection.
• Provides training, leadership and guidance to QA personnel.
• 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 PCIs cultural values and aligns daily actions with department goals and company culture.

• Bachelor’s degree in Life Sciences discipline or equivalent.
• Minimum of four (4) years of relevant experience in documentation review, QA, or equivalent.
• Minimum of one (1) year of functional leadership experience.
• Working knowledge of cGMP regulations 21
  
  CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices.
• Knowledge of cGMP operations within medical device or pharmaceuticals. Fill Finish and Biologics production environments is preferred.

• Champions PCI Pharma Services culture and empowers employees to take responsibility for their jobs and goals.
• Engages employees by creating a climate in which they want to do their best.
• Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
• Maintains employee work schedules.
• Provides oversight and direction to the employees in accordance with PCI Pharma Services policies and procedures.

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 a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled