QA Group Lead - Second Shift (2-10)

QA Group Lead

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.

• Reviews and approves 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.
• Schedules and coordinates quality functions to support cGMP processes.
• Provides oversight, guidance, and quality decision making for cGMP activities.
• Communicates shift team status to other team leaders within QA and other cross functional departments as needed.
• Maintains and communicates team metrics.
• 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.

Essential Job Functions:

• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
• Exhibits 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.
• Embraces PCIs cultural values and aligns daily actions with department goals and company culture.

Education And Experience

• 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 21CFR 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.

Leadership Responsibilities

• 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.

Pay And Benefits

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).