MCS Senior Associate Quality Assurance

Job Title: MCS Senior Associate Quality Assurance
Duration: 12 Months (Possibility of Extension)
Location: 91320, Thousand Oaks, CA

Must be flexible as it is possible worker will start on any shift. Rotate every 6 months.
Day: 6 am-5 pm
Swings: 1 pm-12 am
Graves: 7 pm-8 am
Will change the business they are supporting.
Rotate every 6 months.

The manager is seeking a Senior Associate, Quality Assurance (MCS) to provide real-time, floor-based QA support at the Client's USTO site. This fully onsite role involves rotating between day and swing shifts every six months, beginning on the day shift for training.
The position supports Clinical/Commercial drug substance production and requires cleanroom oversight, batch record review, and acting as a QA liaison during manufacturing and facility events. Ideal candidates will have hands-on QA or manufacturing experience in a GMP environment (preferably within biotech or Client) with strong critical thinking skills prioritized over academic credentials.

A bachelor's degree in Biochemistry, Biology, Chemistry, or related scientific disciplines is preferred but not required. The manager is open to training strong candidates but will not consider those who are purely academic or significantly overqualified without clear justification.
This position supports Client's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas.
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.

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.
• 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.

Basic Qualifications:
High school/GED + 2 years work experience
OR Associate's and 6 months work experience
OR Bachelor's

Top 3 Must Have Skill Sets:

• Flexibility on shifts
• Attention to detail
• Quality background

Day to Day Responsibilities:

• 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.

Red Flags:

• Too many jobs in a short period of time
• Has never worked on a plant floor.

Interview Process:

1. Phone screen (optional)
2. Teams interview