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QA Associate I

3 months ago

Spring Valley, United States Strides Pharma Inc Full time
Job DescriptionJob DescriptionThe Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging. Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues. Communicates to multiple departments and supervision to provide timely process and issue updates. Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement.
Quality Operations:
  • Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule
  • Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements
  • Becomes competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging
  • Follows internal processes related to controlled substances
  • Performs GMP related verifications such as line clearances, cleaning, room inspection, and materials
  • Collects and appropriately labels packaging retain samples, and submits to the archive storage
  • May execute computer data entries in CME, JDE, LIMS, and/or department databases
  • Collects retain samples and performs sample evaluation for Annual Product Review
  • May backup third party product review/release
  • Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components for release testing

Non-conforming events:

  • Responds to and escalates events identified during production to Quality Management
  • Participates in investigations with the Rapid Response Team as needed

Process Improvement:

  • Collaborates with Manufacturing and Quality partners to identify and implement improvements

Compliance:

  • Conducts GMP walkthroughs of facilities
  • Learns how to perform in-process audits to identify adherence to SOPs and BR requirements
  • Actively participates in training events, and maintains currency with assigned training requirements

Safety:

  • Follows all procedures to ensure a safe and compliant work environment
Education:
High school diploma or equivalent with 2-4 years of relevant industry experience (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)

Knowledge:
  • Ability to communicate and work with teams
  • Attention to detail
  • Strong documentation skills
  • Ability to read and interpret SOPs and function within the scope of procedures

Skills & Abilities:

  • Proficiency with basic math skills and basic experience with computers and software applications required
  • Ability to learn new processes and procedures
  • Able to communicate effectively with other departments, management and operational personnel
  • Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
  • Proof-reading skills; ability to identify errors
  • Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs)
  • Experience with Enterprise Resource Planning (ERP) systems is a bonus
  • Ability to work overtime as needed, including occasional weekend shifts
  • This position is a 1st shift role. However, the ability to work full-time 2nd shift hours is a bonus

Physical Requirements:

  • Lift 15 lbs.
  • Walk across plant/warehouse
  • Wear appropriate gowning as required
  • Ability to read and use a computer for extended periods of time