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MCS Senior Associate, Quality Assurance

The Steely Group

Thousand Oaks, CA

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JOB DETAILS
SKILLS
Biochemistry, Biology, Change Control, Chemistry, Communication Skills, Continuous Improvement, Documentation, GMP (Good Manufacturing Practices), High School Diploma, Leadership, Maintain Compliance, Manufacturing, Manufacturing Operations, Multitasking, Organizational Skills, Presentation/Verbal Skills, Production Control, Project Execution, Project Tracking, Project/Program Management, Quality Assurance, Regulations, Standard Operating Procedures (SOP), Support Documentation, System Operations, Systems Analysis, Time Management, Writing Skills
LOCATION
Thousand Oaks, CA
POSTED
1 day ago

Our client is seeking a highly motivated MCS Senior Associate, Quality Assurance to join the team and play a vital role in ensuring the integrity and compliance of manufacturing operations. This onsite position offers an exciting opportunity to contribute to the production of clinical and commercial drug substances. The successful candidate will support quality assurance functions on the production floor, oversee batch records, review standard operating procedures, and act as a key QA liaison during manufacturing and facility events. 

Key Responsibilities:
  • Maintain a purposeful presence on the manufacturing floor to monitor processes and ensure GMP compliance.
  • Review electronic batch records for accuracy, completeness, and adherence to protocols.
  • Facilitate SOP revision, approval, and ensure procedures align with regulatory standards.
  • Approve work orders and minor deviations, ensuring proper documentation and quality oversight.
  • Evaluate compliance issues, provide strategic recommendations, and track resolution progress.
  • Represent the Drug Substance Quality Assurance department in project execution to meet operational goals.
  • Support the quality documentation workflow, including review and approval of deviations and change controls.
  • Assist in fostering a culture of continuous improvement through proactive quality initiatives.

Qualifications:
  • High school diploma or GED with 2 years of work experience; Associate’s degree with 6 months of work; or Bachelor’s degree.
  • Bachelor’s Degree in Biochemistry, Biology, Chemistry, or a related science field preferred.
  • Proven experience with GMP operations, including following SOPs, maintaining training records, and practicing good documentation.
  • Ability to make informed Quality decisions in a regulated environment to ensure compliance.
  • Demonstrated project management skills, including tracking progress and meeting deadlines.
  • Strong understanding of Quality Systems and operational evaluation according to company procedures.
  • Excellent organizational skills with the ability to manage multiple tasks efficiently.
  • Effective written and verbal communication skills.
  • Ability to work both independently and as part of a team, demonstrating leadership and initiative.

Work Location:
Onsite - Thousand Oaks, California

About the Company

T

The Steely Group

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