Quality Assurance Specialist II

Must Have

• Two (2) years of Laboratory QA experience inPharmaceuticals and/or Medical Devise.
• Bachelors degree (B.S/B.A.) or higher in microbiology or related fields.
• In-depth knowledge of microbiology and/or chemistry-related processes and ISO standards.

Job Summary:

The Quality Assurance Specialist II will analyze documents and track Laboratory Quality Control data, workflow, and procedures to meet regulatory and client requirements at our Petaluma, CA Laboratory. 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
• Coordinate the release, tracking, and closure of NCMRs and CAPAs.
• Customer communication, sending out notifications and surveys
• Completing Supplier assessments and evaluations
• File and organize all documents and keep all logs current and complete.
• Manage 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.
• Communicate with customers regarding quality-related items.
• Maintaining Customer validation report logs and requalification due dates

Education:

• Bachelors degree (B.S/B.A.) or higher in microbiology or related fields.

Experience:

• Two (2) years of industry laboratory QA experience.
• Training in QA/QC, and document control.
• Knowledge of laboratory procedures, experimental and/or medical, and engineering/manufacturing design and development.
• In-depth understanding of microbiology and/or chemistry-related terms.
• Understanding of ISO standards and guidelines.
• Substantial understanding of audit principles.

Capabilities:

• High degree of organization skills, clear and precise written, and verbal, communication skills
• Good familiarity with FDA and ISO regulations pertaining to controlled documents.
• Administrative experience and/or background.
• Strong Leadership skills
• Experience and understanding of industry regulations and how to apply them. This may include FDA 21 CFR Part 820, 21CFR Part 11, ISO 17025, 13485 and 9001
• Receiving and updating standard operating procedures.
• Previous working experience with CAPA, Change Control, NCMR, quality events, and validation documentation (IQ/OQ/PQ)
• Strong 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.