Quality Assurance Senior Associate, Biopharma

Quality Assurance Senior Associate, Biopharma

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.

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 send your resume to View email address on click.appcast.io.