Quality Assurance Senior Associate, Biopharma; JP

Position: Quality Assurance Senior Associate, Biopharma (JP10480)
Location: West Greenwich
Job 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:

• 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 ever changing work environment
• Quality assurance or manufacturing experience in the pharmaceutical or medical device industry
• Strong cGMP and GDP behavior

Employee Value Proposition:Growth/ opportunity.

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 you’re not interested in pursuing this position, please feel free to look at the other positions on our  You are welcome to also sharethis opportunity with anyone you think might be interested in applying for this role.
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