PCI Pharma Services

QA Group Lead - Second Shift (2-10)

San Diego, CA, USA · Full-time

Sponsorship not specified$37k-$41kDetected 22 days ago

ComplianceGMPMedical DevicesLeadershipMentoring

About the role

Bridge to thousands of biopharma companies and their patients.
Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise.
Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.

Maintains employee work schedules.
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 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.

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.
Fill Finish and Biologics production environments is preferred.

Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis.
Provides training, leadership and guidance to QA personnel.
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
Embodies PCIs cultural values and aligns daily actions with department goals and company culture.

The hiring rate for this position is $36.54 - $41.10/hour plus eligibility for an annual performance bonus.

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).
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies.

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.
Join us and be part of building the bridge between life changing therapies and patients.

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.
Equal Employment Opportunity (EEO) Statement:

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 o

This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.