QA Technician

**3rd Shift: 4pm to 4am**

Job Description

The Quality Assurance Tech plays a crucial role in ensuring the highest standards of product quality and compliance. The majority of the time will be spent on the production floor, collaborating with the operations team to perform verifications, conduct general walkthroughs, and execute onsite reviews and mini audits. This role requires the ability to initiate solutions to problems, such as initiating deviations, and involves reviewing various documents, including executed batch records, cleaning records, and log books. Issuing batch records as needed is also part of the responsibilities. Approximately 80-85% of time will be spent on the production floor, with the remainder in the office. The role requires adherence to specific gowning requirements, from safety shoes to full gowning.

Responsibilities

• Collaborate with the operations team to perform verifications on the production floor.
• Conduct general walkthroughs and onsite reviews to ensure compliance.
• Execute mini audits to ensure processes are correctly followed.
• Initiate solutions to problems, such as deviations.
• Review and maintain various documents, including batch records and log books.
• Issue batch records as needed.

Essential Skills

• Quality assurance expertise.
• FDA and GMP compliance knowledge.
• Experience with batch record review and document control.
• Audit skills.
• Pharmaceutical industry knowledge.

Additional Skills & Qualifications

• Bachelor's degree in any science discipline preferred.
• 2+ years of experience in a regulated industry (GMP/FDA/ISO).
• For Sr. roles, 5+ years of regulated industry experience.
• For Lead roles, 7+ years of regulated industry experience with potential supervisory responsibilities.

Work Environment

Training occurs on the first shift, Monday to Friday from 8am to 4:30pm, lasting 6-8 weeks depending on skills. Specific gowning requirements are in place, ranging from safety shoes to full gowning.