QA Shop Floor Specialist

Overview

Job Title: QA Shop Floor Specialist

Location: Warren, NJ 07059

Duration: 6 Months

Pay Range: $32.00 - $35.34/hr on W2

Work arrangement: 100% onsite

Work schedule: Wed-Sun: 1st shift

Time: 8:00 AM to 4:30 PM

• Provide QA oversight of Warren Manufacturing Operations, Supply Chain Operations, Warehouse, QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products.
• Participate in Shop Floor and Quality Check Walkthrough programs.
• Printing, issuance, chain of identity (COI) verification, and reconciliation of finished drug product labels used by Manufacturing and Supply Chain Operations.
• Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations, investigations, CAPA, risk management, change control, and product complaints.
• Revise department SOPs, and review and QA approval of CTDO SOPs.
• Perform real-time review/approval of executed batch records and COI verification.
• Responsible for ERP material status changes of production/drug product.
• Maintain current knowledge of industry standards as they apply to cGMPs and global regulatory guidelines.
• Support risk assessments/projects as required by senior management.

• B.S. or M.S. in a related scientific discipline (preferred); equivalent combination of education and experience acceptable.
• 1–2 years of experience within QA functions in the pharmaceutical industry.
• Thorough knowledge of cGMP in the pharmaceutical industry; understanding of the drug development process.
• Experience with batch record review, product disposition/release, change control, SOP review, and GMP inspections.
• Strong computer skills and working knowledge of common business software.
• Excellent organizational, problem-solving, verbal and written communication skills.
• Strong interpersonal skills and ability to work as part of a team; demonstrated initiative and accountability.
• Professional integrity and maturity are required.

Review work performed in a typical office environment. QA Shop Floor Coverage/Lab Walkthroughs require standing and walking up to 90% of a shift. Lighting and temperature are adequate with no abnormal noise or dust conditions.

This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myers-Squibb. Starting hourly compensation for this assignment is in the range $33-$35.34/hr final compensation and benefits are determined by the employer of record.

Equal Opportunity

Employer:

ASK Consulting does not discriminate based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other protected status.

California Applicant Notice and Fair Chance Employment Notice apply where applicable. For details, review our Privacy Notice and related addenda on the ASK Consulting website.

This posting does not constitute an offer of employment. All applicants must be legally authorized to work in the United States. Any offer is at will and may be contingent on background checks where required by law.