Senior Quality Assurance Associate

Payrate: $30.00 - $31.00/Hour

Summary:

Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance.

Primary responsibilities:

• 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
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
• Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations
• Oversee and provide guidance during on-the-floor analytical testing
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
  
  

Requirements:

• Associates and a certificate such as Bioworks and 3-4 YOE or B.S. and 1-2 YOE in a manufacturing or quality background in a manufacturing environment.
• Able to work both independently and within a team environment.
  
  

Skills:

• Knowledge of process and facility equipment, ability to interpret and apply Good Manufacturing Practices (GMP)
• Quality assurance or manufacturing experience in the pharmaceutical or medical device industry
• Written and spoken fluency required.
  
  

Top 3 Must Have Skill Sets:

• Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment . Strong GMP and GDP Behaviors.
• Knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems, experience with deviations
• Demonstrated ability to work as a team player and independently. Strong communication skills and ability to complete assignments and meet timelines.
  
  

Pay Transparency: The typical base pay for this role across the U.S. is: $30.00 - $31.00 per hour. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

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