MCS Senior Associate Quality Assurance

Position : MCS Senior Associate Quality Assurance

Location : Thousand Oaks, CA (Fully Onsite)

Competitive Compensation : $35 / hr - $37 / hr

Shifts Available :

Day Shift : 7 AM - 8 PM or 6 AM - 5 PM

Swing Shift : 1 PM - Midnight

Night Shift : 7 PM - 8 AM

Are you a quality assurance professional with a passion for GMP operations and compliance oversight? We are looking for an MCS Senior Associate Quality Assurance to join our dynamic team in Thousand Oaks, CA.

This is a fully onsite role where you'll play a crucial part in supporting our Quality Assurance program under the Plant QA organization, ensuring the highest standards in Drug Substance manufacturing areas.

Job Summary :

The MCS Senior Associate Quality Assurance will provide daily oversight of Drug Substance manufacturing areas, ensuring compliance with GMP operations and quality systems.

You'll be involved in batch record reviews, SOP revisions and approvals, managing minor deviations and CAPA records, and leading process improvement projects.

This role requires working closely with various departments in a team matrix environment to achieve operational goals.

Top Responsibilities :

• Ensure compliance oversight to Manufacturing and Facilities & Engineering areas / staff.
• Review electronic batch records, revise and approve SOPs, approve work orders, and manage quality approval of minor deviations and CAPA records.
• Maintain a purposeful presence on the manufacturing floor to oversee and support quality compliance.
• Represent the Drug Substance Quality Assurance department in project execution to achieve departmental operational goals.
• Collaborate with various departments in a team matrix environment.
• Recommend and lead process improvement projects based on best practices and compliance requirements.
• Evaluate new technologies for potential application as new processes or modifications to existing procedures.
• Evaluate compliance issues, provide recommendations, and ensure the progress of quality records to completion.
• Communicate identified trends, quality risks, and recommendations to internal and external stakeholders.

Required Skills :

• 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.

If you are a dedicated quality assurance professional with a keen eye for detail and a passion for compliance, we want to hear from you.

Apply now to join our team in Thousand Oaks, CA, and contribute to our mission of delivering high-quality drug substances.

About SSi People :

With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team.

Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly.

More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.