PCI Pharma Services

QA Associate III

San Diego, CA, USA · Mid · Full-time

Sponsorship not specified$30k-$33kDetected 14 days ago

ComplianceERPGMPMicrosoft Office

About the role

Bridge to thousands of biopharma companies and their patients.
include supporting audits, training programs, and documentation review for GMP operations.
It also generates and reviews documentation for batch disposition and batch record assembly.

The role promotes a compliant cGMP environment by following SOPs and provides quality support for investigations related to GMP manufacturing events.
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.
This position performs a range of routine and semi-routine QA Raw Materials activities to ensure compliance with Quality Assurance and regulatory requirements.

Bachelor's degree strongly preferred in a Life Sciences discipline or equivalent.
Must be familiar with Microsoft Office applications.

Assists in regular follow ups with end users to ensure timely completion of open investigations and investigation activities.
Generates and compiles lot file review documentation for batch disposition.
Updates lot status in ERP system.
Responsible for equipment inductions, revisions and record maintenance within the electronic database.
Creates, revises and approves procedures.
Assists with internal, client and regulatory audits.
Assists with the generation of department metrics.
Assists with developing recommendations for continuous improvement projects.
Assists in the review and approval of production batch records and associated data for product disposition.
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
Fosters a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures.
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.

The hiring rate for this position is $29.65 - $33.36/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.
The individual can work independently, within guidelines, and as part of a team.

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.