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MCS Senior Associate Quality AssuranceSpectraforce Technologies • Thousand Oaks, California, United States
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MCS Senior Associate Quality Assurance

Spectraforce Technologies
  • US
    Thousand Oaks, California, United States
  • US
    Thousand Oaks, California, United States
Postuler Maintenant

À propos

Job Title: MCS Senior Associate Quality Assurance
Duration: 12 Months, Possibility of Extension
Location: Thousand Oaks, CA
Shift Details
Day: 6 AM - 5 PM
Swing: 1 PM - 12 AM
Night: 7 PM - 8 AM
Role will begin on Day shift, then transition to Night shift approximately 1 month after training.
Role Summary This position supports the Client's Quality Assurance (Plant QA) organization by providing daily oversight of Drug Substance manufacturing areas. Under general supervision, the Sr. Associate ensures compliance, supports operations, and reviews quality documentation.
This is a hands‑on, GMP‑focused QA support role that requires individuals who are proactive, independent, detail‑oriented, and comfortable working in a high‑volume, cross‑functional environment.
Not suitable for fresh graduates or short‑term job seekers. FTE conversion potential is prioritized for long‑term candidates.
Key Responsibilities
Provide purposeful on‑the‑floor PQA support to Manufacturing and Facilities/Engineering teams.
Review and approve electronic batch records (BRRs), deviations, SOPs, and work orders.
Ensure GMP compliance, accuracy, and documentation integrity.
Identify, evaluate, and elevate compliance issues appropriately.
Provide recommendations and drive quality records to closure.
Assist with departmental projects to support operational goals.
Maintain training compliance and support routine QA operations.
Required Qualifications
High School/GED + 2 years work experience or Associate's degree + 6 months work experience or Bachelor's degree.
Preferred Qualifications
Bachelor's degree in Biochemistry, Biology, Chemistry, or related scientific field.
Demonstrated experience performing GMP operations, following SOPs, and maintaining documentation accuracy.
Ability to make quality‑based decisions to ensure compliance.
Experience managing projects and meeting timelines.
Experience evaluating documentation and operations per company procedures.
Strong organizational skills and ability to handle multiple tasks simultaneously.
Effective written and verbal communication skills.
Experience working with Quality Systems.
Ability to work both independently and as part of a team.
Demonstrated leadership attributes and experience driving improvement initiatives.
Top 3 Must‑Have Skills
Strong organizational skills
Critical thinking capability
Team player mindset
Nice to Have: Batch record review experience
Day‑to‑Day Responsibilities
Provide PQA on‑the‑floor support for Manufacturing.
Perform record review and approval for BRRs, deviations, and SOPs.
Support cross‑functional operations in a GMP environment.
Additional Details
Reason for Opening: Supplemental workload.
Possible Extension: Yes.
Red Flags:
Frequent job changes
No GMP experience
Recent graduates (no hands‑on GMP experience)
Interview Process:
Phone interview with Manager
Second‑round panel with team members
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  • Thousand Oaks, California, United States

Compétences linguistiques

  • English
Avis aux utilisateurs

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