QA Group Lead

PCI Pharma Services•San Diego, CA

3d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Fill Finish and Biologics production environments is preferred.

Responsibilities

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.
Coaching 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.
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.