Novato, CA
QA Operations Associate
Job Title: QA Operations Associate
Location: Novato, CA Digital Dr, 94949
Pay Rate: $38.50/ HR
4-month W2 Contract with potential to extend/ convert
Job Summary:
The QA Operations Associate will play a critical role in ensuring quality oversight of manufacturing processes for protein-based products. This position requires a strong understanding of GMP (Good Manufacturing Practices) and attention to detail. The successful candidate will be responsible for reviewing documentation, ensuring regulatory compliance, and maintaining records in alignment with company policies and global standards.
Key Responsibilities:
- Quality Oversight: Provide quality oversight of specific operations within the manufacturing process, ensuring all procedures align with GMP regulations, company policies, and industry standards.
- GMP Documentation Review: Review and validate GMP documentation, including but not limited to logbooks, production batch records, and electronic buffer and media batch records.
- Record Management: Scan and archive executed production batch records, ensuring accuracy, accessibility, and compliance with internal and external regulatory requirements.
- Regulatory Compliance: Ensure adherence to regulatory licenses, GMP standards, and company guidelines. Familiarity with US and European regulatory requirements is essential; knowledge of other jurisdictions is a plus.
- Collaboration & Reporting: Collaborate with cross-functional teams and management to ensure proper documentation is in place. Support the QA team with ad-hoc projects and duties as assigned.
Desired Skills & Competencies:
- Batch Record Review, QA, GMP, Archiving, Oracle EBS
- Attention to Detail: Ensure the accuracy of records and documentation, identifying discrepancies that may affect production quality.
- GDP Understanding: A solid grasp of Good Documentation Practices (GDP) is required for maintaining thorough and compliant records.
- Technical Skills: Proficiency in Microsoft Office and Oracle EBS is required. Experience with SQL or similar database systems is a plus.
- Office Equipment Proficiency: Ability to operate basic office equipment, including scanners and printers, to support record management and documentation processes.
Education & Qualifications:
- Minimum Requirement: Associate degree or higher in a relevant field.
- Preferred: Experience in production and batch records review within a GMP-regulated environment.
Additional Information:
- Work Environment: This role is critical in maintaining the integrity of the manufacturing process. Candidates must be comfortable working in a regulated, fast-paced environment.
- Opportunities for Growth: The company offers the potential for long-term career advancement and development within the quality and compliance sector.