Quality Assurance Senior Associate Biopharma JP10480
Quality Assurance Senior Associate Biopharma JP10480
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Salary Not Disclosed
1 Vacancy
Job Description
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 aQuality Assurance Senior Specialistfor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
Plant Quality Assurance (PQA) onthefloor position will work directly with plant manufacturing and support groups for ongoing bulk drug substance manufacturing.
Primary responsibilities of this position include:
- Provide ongoing 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 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 MustHave 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 sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Required Experience:
Senior IC
Employment Type
Full Time
