QA Group Lead - Second Shift (2-10)

PCI Pharma Services; San Diego (CA); On-site; USD 50,337 - 56,619; Full time

Benefits offered by this job

Health insurance

Paid time off

401(k)

Job summary

PCI Pharma Services in San Diego is seeking a QA Group Lead to oversee compliance with regulatory requirements, providing leadership to QA personnel. You will coordinate quality functions, monitor team metrics, and independently troubleshoot QA issues.

The ideal candidate has a Bachelor's degree in Life Sciences and at least four years of relevant experience in QA. The position offers a competitive salary and a comprehensive benefits package.

Qualifications

• 4+ years of relevant experience in documentation review, QA, or equivalent.
• Minimum of 1 year in a functional leadership role.
• Familiarity with cGMP operations within medical devices or pharmaceuticals.

Responsibilities

• Leads the review and approval of executed technical documentation.
• Coordinates quality functions to support cGMP processes.
• Independently investigates and rectifies QA issues.

Skills

Documentation review

Knowledge of cGMP regulations

Leadership

Problem-solving

Education

Bachelor’s degree in Life Sciences

Job description

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.

ESSENTIAL JOB FUNCTIONS – OTHER DUTIES MAY BE ASSIGNED

• 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.

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.

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

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.

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