Quality Assurance Specialist

Quality Assurance Specialist I

Must Have

• 1 to 2 years of Quality Assurance laboratory experience in Pharmaceutical/Medical devices preferred
• Bachelor’s degree (B.S/B.A.) or higher in microbiology or related fields.
• Knowledge of microbiology and/or chemistry-related processes and ISO standards.

Job Summary:

The Quality Assurance Specialist will analyze documents and track Laboratory Quality Control data, workflow, and procedures to meet regulatory and client requirements at our Petaluma, CA Laboratory. Working closely with the Operations manager and Regional Quality Manager, candidates in this onsite position will initiate and process various quality protocols, verifying work orders and maintaining a multitude of quality assurance records within the laboratory for Clean Room Validation and Monitoring, Water Testing, Bioburden, LAL, Sterility for Medical Device, Micro Sequencing, and EM P-I, etc.

Essential Duties/Responsibilities:

• Review of daily WHO (work order history), verifying and approving WHO in Labapp
• Maintain DCO, SOP, FRM, NCMR, CAPA, Deviation, Complaints/Inquiries, WOH (work order history), quality data sheets/records, Calibration records, training records, and logs.
• Initiate and process DCOs, NCMR, and CAPAs and participate in related investigations and document findings with data
• Synchronize the release, tracking, and closure of NCMRs and CAPA’s.
• Work closely with customers regarding quality-related items while sending out notifications and surveys
• Maintaining Customer validation report logs and requalification due dates
• Completing Supplier assessments and evaluations
• File and organize all documents and keep all logs current and complete.
• Maintain the Controlled Document System in compliance with FDA's Quality Management System (QMS) according to EU ISO Standards and company policies.
• Ensuring all ISO standards are current.
• Aid with ISO audits.
• Review records for GMP compliance and consistency with company policies and procedures necessary to support customers’ quality requirements.
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Education:

• Bachelor’s degree (B.S/B.A.) or higher in microbiology or related fields.

Experience:

• 1 to 2  years of industry laboratory QA experience.
• Experience in QA/QC, and document control.
• Knowledge of laboratory procedures
• Specific understanding of microbiology and/or chemistry-related terms.
• Understanding of ISO standards and guidelines.
• Understanding of audit principles.

Capabilities:

• Excellent organization skills, clear and precise written, and verbal, communication
• Familiarity with FDA and ISO regulations pertaining to controlled documents.
• Administrative experience and Document control.
• Previous working experience with CAPA, Change Control, NCMR, quality events, and validation documentation (IQ/OQ/PQ) is a plus.
• problem-solving skills include: root cause analysis using formal RCA tools such as Ishikawa and 5Y's
• Able to successfully pass background and drug screening
• Substantial organizational skills, and ability to multitask in a dynamic, fast-paced environment
• Strong analytical and logic skills with a focus on fact-based decision-making and problem-solving

Infinity Laboratories is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.