QA Technician I (3rd shift) (Sun 10p-Fri 6:30a)

QA Technician I

Job Summary:

Responsibilities:

• Make disposition of materials affected by quality incidents such as OOS in-process results, foreign materials, spills, equipment failure etc. with Quality management oversight.
• Isolation and evaluation of adulterated products.
• Determine next course of action for continuation of production with Quality management oversight.
• Communicate and document actions taken.
• Directing Operations floor management on course of actions for quality events with Quality a higher degree of management oversight.
• Requires interaction with management on some routine events.
• Review live batch records for completeness and compliance.
• Audit of the facility for ongoing cGMP compliance.
• In the absence of a supervisor and/or Team Lead, assume the responsibility for operational decisions. 
• Release equipment for use.
• Verify cleanliness of equipment.
• Issue supplemental cGMP documentation.
• Training personnel for inspection activities.
• Issuance and management of supplemental inspection system.
• Gather data for quality assessors and management.
• Gather data for triage processes.
• Participate in triage.
• Identify and update SOP discrepancies as continuous improvement.

Education/Qualifications:

• High School Diploma/GED Required
• Two years of experience in the pharmaceutical industry and knowledge of cGMP is necessary.
• Understanding the basic functionality in the areas of production, packaging, or validation or an equivalent education in a science related discipline is required.
• Demonstrated ability to prioritize, organize and work effectively.
• Strong observational skills and attention to detail are required.
• Strong communication skills (both oral and written) for internal contacts are required.
• Strong follow-up skills and the ability to provide timely closure of assigned tasks.
• Strong technical writing and problem solving skills. Experience in reviewing scientific documents/reports to assure compliance.
• Computer skills are required. Proficiency in the following are desired: Microsoft Word, Microsoft Excel and Microsoft Access.
• Strong interpersonal skills with the ability to achieve consensus and cooperation with varying departments and personalities.
• May rely on other Technicians for experience and decision making.
• Personnel are expected to walk throughout the facility up to 90% of the time on shift.
• Personnel may be required to lift up to 50 pounds.