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Quality Assurance Senior Associate, Biopharma (JP10480)
West Greenwich, RI · Biotech/PharmaceuticalJob Title: Quality Assurance Senior Associate, Biopharma (JP10480)
Location: West Greenwich, RI.
Employment Type: Contract
Business Unit: Plant Quality Assurance
Duration: 10 months with likely extensions or conversion to permanent
Job Posting Date: 6/28/2022
3 Key Consulting is hiring a Quality Assurance Senior Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing.
Primary responsibilities of this position include:
Skills:
Why is the Position Open?
Supplement additional workload on team.
Top Must-Have Skill Sets:
Red Flags:
No previous experience, inability to gown up per requirements for manufacturing and support on the floor operations.
Interview process:
Virtual 3 interviews with some key players
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
Location: West Greenwich, RI.
Employment Type: Contract
Business Unit: Plant Quality Assurance
Duration: 10 months with likely extensions or conversion to permanent
Job Posting Date: 6/28/2022
3 Key Consulting is hiring a Quality Assurance Senior Specialist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing.
Primary responsibilities of this position include:
- Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
- Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to equipment used records, work orders, job plans, reports and batch records.
- Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
- Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations.
- Complete required assigned training for self to permit execution of required tasks.
- Perform training activities, as needed.
- Support operational improvement initiatives, programs and projects.
Perform walkthroughs/inspections of areas to ensure housekeeping and GMP are maintained
Skills:
- Quality assurance or manufacturing experience in the pharmaceutical or medical device industry
- Strong cGMP and GDP behaviors
- Strong word processing, presentation, database and spreadsheet application skills
- Strong organizational skills and ability to manage multiple tasks at one time
- Knowledge of electronic systems including LIMS, Trackwise, and Maximo.
Why is the Position Open?
Supplement additional workload on team.
Top Must-Have Skill Sets:
- Ability to work in teams, flexible to work in an everchanging work environment
- Quality assurance or manufacturing experience in the pharmaceutical or medical device industry
- Strong cGMP and GDP behavior
Red Flags:
No previous experience, inability to gown up per requirements for manufacturing and support on the floor operations.
Interview process:
Virtual 3 interviews with some key players
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
Regards,
3KC Talent Acquisition Team