Job Details

  • Title: QA Associate
  • Code: RCI-17096-1
  • Location: Andover Massachusetts (MA) 01810
  • Posted Date: 12/02/2019
  • Duration: 18 Months
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  Job Description

  • This global role is responsible for the Quality Assurance Validation (QAV) support to the clinical Pharmaceutical Sciences Biotherapeutic Manufacturing and Laboratory Facilities.
  • This role will be located at the Company’s Andover, MA site with primary support to the Andover facilities.
  • This will include QAV support to all areas including utility, manufacturing (cell bank, drug substance and drug product), laboratory and related computer systems.
  • This role is responsible for the review of all documentation related to validation activities as well as procedures, change controls, Investigations and commitments.
  • Candidate is responsible for providing Quality Assurance support to GMP manufacturing and testing operations relative to production and disposition of clinical trial material.
  • This includes tech transfer and disposition deliverables such as review of batch records, protocols and reports, environmental data, investigations, CAPAs, SOPs, test methods, validation qualifications, change controls, and other GMP documentation to ensure compliance with global board of Health regulations

Position Responsibilities:

  • Review and/or approve various GMP documents, primarily batch records and investigations and including procedures, change controls, validation qualifications, and CAPAs.
  • Provide Quality Assurance support for the validation program at the Andover, MA company site including utility, manufacturing, laboratory and computer systems.
  • There will be opportunities to support other sites in company’s global network on an ad hoc basis.
  • Primary role includes validation documentation review and approval including specifications, protocols, testing documents, vendor assessments, summary reports, data integrity assessments, higher level validation plans, program documentation and strategies as well as any supporting documentation associated with maintaining of the validated state.
  • Review and approve change controls, investigations, commitments and procedures.
  • Understanding of the quality role for maintaining and onboarding new equipment, instruments and systems.
  • Able to seek out and assess internal and external compliance with applicable regulations.
  • Contributes to the interpretation of cGXPs for the clinical environment.
  • This includes computerized system and data integrity compliance.
  • Ability to make quality decisions to resolve issues when choosing between multiple options.
  • Able to recognize when an issue is beyond their sphere of influence and escalates immediately.
  • Responsible for knowing, understanding and acting in accordance with company’s values.
  • The successful candidate will possess strong interpersonal, teamwork, and collaboration skills.
  • Support the site relative to a constant state of inspection readiness.
  • Participate in audits relative to this role as needed.

Organizational Relationships:

  • Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
  • Andover Clinical Manufacturing facility Operations group, Bioprocess Research and Development (BRD), Analytical Research and Development (ARD), Engineering and Maintaenance Unit (EMU), Andover Site PGS Quallity Assurance.

Education & Experience:

  • Minimum Educational Requirements- bachelor’s degree with 5-8 years of experience or master’s degree with 6 years of experience in related engineering or biological sciences.
  • Ideal candidate would have Biopharma industry experience that includes an understanding of the validation of laboratory and bioprocessing equipment and systems.
  • In addition, knowledge of global GMP and regulatory requirements related to validation principles as it relates to drug substance and drug product.

Technical Skills Requirements:

  • Experience in Quality Assurance possessing strong quality culture is desirable.
  • Team player with strong interpersonal, organizational, and communications skills are a must.
  • Must have the ability to collaborate and enable quality thinking within the business lines.
  • Additionally, candidate must be self-motivated, engaged and able to perform moderately complex tasks independently.

Physical Position Requirements:

  • Examples: Lifting, sitting, standing, walking, ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc.
  • Mental agility to handle a large quantity and broad scope of different types of quality assurance work.
  • Ability to independently problem solve and make recommendations for solutions.
  • Role is primarily office-sitting, standing, walking and bending.
  • This may be inclusive of leading/participating in WebEx meetings.
  • 90% office work, 10% observe manufacturing process
  • GMP experience is a must
  • Pharma GMP experience preferred
  • Main focus is on Validation experience
  • 5-8 years’ experience as an QA associate
  • Understand validation process, protocols, evaluations, execution
  • Potential to then support batch records and formulation review
  • Team player, multitask, collaborate with other teams