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Quality Assurance Specialist

Advanced Bio-Logic Solutions Corp West Greenwich, RI
  • Posted: over a month ago
  • $32 to $37 Hourly
  • Contractor
  • Benefits: Vision, Medical, Life Insurance, 401k, Dental

Top 3 Must Have Skill Sets:

  • Commissioning and Qualification
  • Technical Writing
  • Quality oversight

Day to Day Responsibilities:

  • Review & approve documents
  • On the floor oversight of activities
  • Attend meetings & report metrics/ status

Summary

  • Ideal candidate- 5+ years industry experience.
  • Commissioning and Qualification experience.
  • experience with CAPA, validation, Technical Writing.
  • Quality oversight.

Responsibilities:

  • Quality oversight of AR 30 startup activities for facilities, utilities, equipment, systems and process with alignment and integration into the Amgen Quality Systems, including:
  • Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental qualification protocols/reports, validation protocols/reports.
  • Oversee execution of and change management related to the following: factory acceptance, commissioning tests, facility qualifications and validation activities.
  • 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 facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations.
  • Oversee and provide guidance during on-the-floor analytical testing.
  • Audit and inspection support
  • 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.
  • Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
  • Assess changes that could potentially impact product quality.
  • Provide management updates (via various reporting tools) on metric performance to goals and alert senior management of quality, compliance, supply and safety risks.
  • Complete required assigned training for self, and ensure training of staff, to permit execution of required tasks.
  • Perform training activities, as needed.

Advanced Bio-Logic Solutions Corp

Address

West Greenwich, RI
02817 USA

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