Associate Quality Assurance - Biopharmaceutical

Company: Collabera
Location: Thousand Oaks
Posted on: April 5, 2025

Job Description:

Sr. Associate Quality Assurance - Biopharmaceutical Manufacturing

While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.

Work Schedule:
(24/5 Operation - Building 20) Rotating 3-Month Shifts:

Morning: 6:00 AM - 3:00 PM
Swing: 2:00 PM - 11:00 PM
Graveyard: 8:00 PM - 7:00 AM (10 hours of work + 1-hour lunch)
Training: New hires typically start on the morning shift.
Commitment: Must be able to work all three shifts.

Pay Range:

$30 - $37 an hr.

Job Responsibilities:

Provide quality oversight on the manufacturing floor.


Perform inspection support, electronic batch record review, and QA assessments.


Review and approve SOP revisions, work orders, job plans, deviations, CAPAs, and MES revisions.


Ensure compliance with GMP operations and quality systems.


Evaluate compliance issues and provide recommendations.


Represent Drug Product Quality Assurance in projects supporting departmental goals.



Ideal Candidate Profile:

2-5 years of QA experience in a biopharmaceutical GMP manufacturing environment.


Strong understanding of aseptic techniques, gowning procedures, and presence inspection.


Flexibility to rotate across all three shifts every three months.


Detail-oriented, team player, strong work ethic, and excellent communication skills.


Proactive mindset - ability to identify and address quality concerns confidently.


Fast-paced environment - dependable, committed, and passionate about quality assurance.



Preferred Qualifications:

Bachelor's Degree in Biochemistry, Biology, Chemistry, or a related scientific field.


Experience in GMP operations, following SOPs, and maintaining documentation practices.


Strong background in quality systems and compliance oversight.


Proven ability to manage projects and meet deadlines.


Excellent organizational and multitasking skills.


Strong written and verbal communication abilities.


Leadership qualities and initiative in driving process improvements.


Solid understanding and application of aseptic behaviors and principles.

Keywords: Collabera, Bakersfield , Associate Quality Assurance - Biopharmaceutical, Other , Thousand Oaks, California