Job Description
Position Title: MCS Senior Associate Quality Assurance
Work Location: Thousand Oaks, CA 91320
Assignment Duration: 3 months
Work Schedule: Must be flexible as it is possible worker will start on any shift. Rotate every 6 months. DAY 6AM - 3PM SWING 3 PM to Midnight Will change on the business they are supporting Rotate every 6 months
Work Arrangement: Fully onsite role involves rotating between day and swing shifts every six months, beginning on day shift for training.
Position Summary: The manager is urgently seeking a Senior Associate, Quality Assurance (MCS) to provide real-time, floor-based QA support at client’s site.
Background & Context: This position supports our organization’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. This role is a priority hire due to the team running very lean; coverage is critical to supporting production without strain.
Key Responsibilities:
- Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems.
- Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations.
- Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
- The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.
- The staff will be providing on-the-floor support for GMP manufacturing operations, Batch Record Review, and deviation support.
Qualification & Experience:
- Preferred Qualifications: •Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field.
- Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices. Also, ability to make Quality based decisions in order to ensure compliance.
- Experience managing projects through to completion & meeting timelines.
- Evaluating documentation and operations according to company procedures.
- Experience working with Quality Systems, Strong organizational skills and ability to manage multiple tasks at one time/ Effective communication skills (both written and verbal)
- Demonstrated ability to work as both a team player and independently
- Display leadership attributes and drive improvement initiatives.
- Ideal candidates will have hands-on QA or manufacturing experience in a GMP environment with strong critical thinking skills prioritized over academic credentials.
- Basic Qualifications: High school/GED + 2 years work experience OR Associate’s and 6 months work experience OR Bachelor’s
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 34.00/hr.