Position Title: MCS Senior Associate Quality Assurance
Work Location: Thousand Oaks, CA 91320
Assignment Duration: 12 months (possible extension)
Work Schedule: Standard 8:00 AM – 5:00 PM, overtime possible during audits/inspections with prior approval, no weekend work expected

Position Summary:
Mid-level quality professional supporting audits, inspections, and management review activities in a pharmaceutical or biotech setting.

Key Responsibilities:

• Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures.
• Supports Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Supports that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
• May perform review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformances, CAPAs, Change Control records and validations. May also support execution of these tasks.
• Supports ATO Management Review activities and metric control plan adherence.
• Supports and audits and inspections preparation, planning, execution and response activities as well as facilitating compliance of compliance and regulatory requests.
• Supports Continual Improvement initiatives, programs and projects.
• Alerts management of quality, compliance, supply and safety risks.
• Represents the quality management systems during audits and inspections.
• Supports internal/external audits and inspections as part of the audit/inspection management team.
• Completes required assigned training to permit execution of required tasks.
• Responsible for complying with Good Manufacturing Practices and Good Documentation Practices.

 
Qualifications & Experience:

• Mid-level quality professional with strong GMP experience and a background supporting audits, inspections, or management review activities in a pharmaceutical or biotech setting.
• Critical thinking, strong communication skills, and a project management mindset.
• Comfortable working cross-functionally and engaging with regulatory bodies, and should thrive in fast-paced, ambiguous environments.
• Familiarity with systems like C-Docs, Smartsheet, SharePoint, and QMS tools is a plus.
• A degree is not required, but competency, adaptability, and professionalism are key.
• Presenting during audits and inspections is likely which includes regulatory bodies (i.e., FDA, TGA, etc.), partners and internal functions.
• Staff will be asked to go into clean areas to support preparation activities.

 

 


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: $32.00/hr.