Quality Assurance Inspector

Job Description

Quality Assurance Inspector

Location: Marietta, GA
Industry: Pharmaceutical
Hours : M-F, 12pm-8:30pm or 2pm-10:30pm. Training will be performed on 1st shift, M-F 6am-2:30pm. One must be flexible to work various hours/shift, OT and weekends.
Salary: $23/hr.-$25/hr. depending on experience. 6.25% shift differential on 2nd shift.
Employment Type : Contract with the possibility to go perm (depends on client needs, performance, attendance, etc.)


Environment:
Client is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing specialty products. Our diversified product portfolio in the specialty neurology and women's health space, together with our non-promoted complex formulations of generic drugs, form the foundation of our unwavering commitment to improve patients' lives.

Position Overview
The Quality Inspector is primarily responsible for supporting activities on the production floor. This includes room release, line clearance, in-process batch record review or post-executed review to ensure proper good documentation practices are followed. Provide quality oversight to all production areas to ensure product quality and compliance to cGMPs. This person works closely with operations personnel ensuring cGMP concerns are identified and resolved appropriately. Must be available/flexible to work second or third shift and weekends.

Duties and Responsibilities

• Required to be on-the-floor and present to provide quality oversight for all critical manufacturing and packaging processes.
• Perform QA release and line clearance inspections, AQL checks on product.
• Perform Label Control functions (issuance and reconciliation).
• Conduct review of batch records.
• Identify deviations and ensure investigations are initiated by the appropriate personnel.
• Clearly communicate complex issues to Management personnel.
• Support creation / revision of SOPs to reflect current practices.
• Assist with FDA and other regulatory inspections.
• Perform all activities in compliance with our Quality System, site environmental, health and safety rules; and applicable FDA and international regulations.
• Maintain knowledge of current regulatory requirements pertaining to drug product manufacture.
• Perform additional duties and responsibilities as assigned.

Requirements:

• High School Diploma or equivalent or technical school certificate.
• Two years of experience in, or support of, pharmaceutical or biotech GMP manufacturing.
• Proficient knowledge of a GMP production facility, manufacturing processes, and/or inspection processes.
• Demonstrated understanding and application of cGMP, current industries practices and relevant guidance.
• Excellent written and verbal communication skills.
• Ability to multi-task effectively.
• Quality Assurance experience a plus.
• Position requires the ability to work independently and effectively in all areas of communication, collaboration, and decision-making.
• Great attention to detail with ability to work on multiple projects.
• Ability to organize and adapt to organization priority changes and work effectively with minimal supervision / independently with a sense of urgency.
• Computer experience required; Proficiency in Microsoft Office (Word, Excel).

EOE/ADA
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