PCI Pharma Services

QA Specialist I

San Diego, CA, USA · Full-time

Sponsorship not specifiedDetected 22 days ago

ComplianceExcelGMPCommunicationMentoringOrganizational SkillsMicrosoft Office

About the role

Bridge to thousands of biopharma companies and their patients.
Summary of objective: The QA Specialist I, ACM is a key member of the aseptic operations team.
This role is responsible for real-time continuous monitoring of all aseptic processing activities within the clean rooms.

Observe and document real-time activities during manufacturing operations, including setup, filling, environmental monitoring, sanitization and routine/corrective interventions. Includes media fill (aseptic process simulations).
Collaborate with Quality Assurance, Operations, Microbiology, and Training to identify opportunities for coaching, retraining, and continuous improvement.
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.

Minimum of 0-2 years of relevant experience in manufacturing or quality positions
Excellent verbal and written communication skills must be comfortable providing real-time coaching.
Ability to make risk-based decisions and resolve issues with minimal guidance
Proficiency in MS Office including Word, and Excel
Ability to work in a dynamic, fast-paced work environment
Creative with the ability to work with minimal supervision and balance with independent thinking
High School Diploma required. Bachelor's Degree in a relevant scientific discipline preferred.
Understanding of aseptic techniques, contamination control, and cGMP regulations (21 CFR Parts 210/211, EU Annex 1).
Demonstrated ability to observe critically and document behaviors accurately and objectively.
Exceptional organizational skills and attention to detail
Honesty, integrity, respect and courtesy with all colleagues
Resilient through operational and organizational change
The hiring rate for this position is $21.69 - $24.41/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).

High School Diploma required.
Bachelor's Degree in a relevant scientific discipline preferred.
1+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production in the pharmaceutical or biotech industry preferred.

The hiring rate for this position is $21.69 - $24.41/hour plus eligibility for an annual performance bonus.

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/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.

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.