PCI Pharma Services · 3 hours ago
Sr. QA Associate I
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$36.54/hr - $41.11/hr
4+ years expPCI Pharma Services is a company that focuses on life-changing therapies and has a global impact. The Sr. QA Associate I role is responsible for ensuring compliance in manufacturing areas, reviewing and approving documentation, and driving process improvements while providing quality expertise to operational staff.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas
Independently reviews and approves production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices
Independently performs quality operations within multiple manufacturing departments
Participates in multiple process improvement projects
Develop, revise, review and approve controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and tech transfer forms
Reviews and approves executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product. Represents QA for high profile clients
Provides quality oversight of quality reports including deviations, corrective and preventive actions (CAPAs) and risk management plan (RMP)
Provides quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions
Supports the Facility/Equipment/Process Change Control System including developing recommendations for change tasks, managing timelines, and performing follow-ups to evaluate the effectiveness of changes
Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
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 PCI Pharma Services’ cultural values and aligns daily actions with department goals and company culture
Qualification
Required
High school diploma or equivalent required. Bachelor's degree preferred in a Life Sciences discipline or equivalent relevant experience required
Minimum of four to six (4-6) years of experience in documentation, QA, Manufacturing, technical quality, validation, or equivalent
Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity
Detail oriented and strong interpersonal and verbal communication skills
Preferred
Knowledge of Fill Finish and Biologics production environments preferred
Familiarity working with electronic batch records
Benefits
Paid time off
Health insurance coverage (including dental and vision)
A flexible spending account
A 401(k) plan
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase