Senior Specialist, QA

Job Description

The Senior Specialist, QA is responsible to aid in the maintenance and improvement of the Quality Systems and infrastructure appropriate for compliance with GMP requirements.  The Senior Specialist, QA has shared responsibility for reviewing data prior to it being submitted to clients, performing Internal Audits, Supplier Qualification and Management, Change Control and Materials Review.

Key Responsibilities

  • Review of data to include test methods, qualifications, and validation data.
  • Aid in supplier management.
  • Performs internal supplemental audits of a technical discipline to verify that facility records (e.g., equipment, training files) are in conformance to applicable SOP and regulatory requirements.
  • Ensures systems used in QA are properly maintained (e.g., QA audit records, training records).
  • Performs protocol, data, report, and in-lab internal audits in a technical discipline to verify conformance to applicable SOP and regulatory requirements.
  • Evaluates responses to internal audit reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.
  • Notifies management of quality/compliance trends and service failures.
  • Monitor regulatory and industry trends/actions and report as needed.
  • Facilitates changes to SOPs, policies, training materials, and other documents for a technical discipline.
  • Assists during regulatory inspections.
  • Provide Support for laboratory failure investigations.
  • Provide support for laboratory deviation investigations.
  • Provide support for Change Control within the organization
  • Provide Materials Review and release when needed.

Job Requirements

Education and Experience

  • B.S. degree.
  • Preferred 2+ years of Quality Management experience.​
  • ASQ Certified Quality Auditor certification or equivalent experience is preferred.

Skills

  • Strong basic math skills with emphasis on data entry (alpha numeric), and common scientific calculations. 
  • Strong basic statistic skills.  Required Statistic skills include calculations of Means, standard deviations, percent error as well as probabilities.
  • Basic understanding of ICH, FDA, and EMA regulatory and/or guidance documents as well as US and international pharmacopeia, as related to quality assurance activities.
  • Ability to anticipate and adjust to rapidly changing priorities and anticipate the impact of the change.
  • Ability to multi-task and adjust to changing deadlines.
  • Ability to work independently and in a team-based environment.
  • Intermediate to advance level knowledge in Microsoft Office and Adobe applications.​

Organizational Relationships

  • The Senior Specialist, QA reports to the Manager, GMP QA.​

About Prolytix

Prolytix, formerly Haematologic Technologies (HT), is a leading provider of analytical and bioanalytical services to support the research, development, and commercialization of large molecule biotherapeutics and reagents for coagulation research. Prolytix builds on 30+ years of expertise to identify and solve the most complex large molecule challenges. Prolytix’s expertise in protein biochemistry supports biotherapeutics from discovery through commercial release, with biopharma services all performed in fully compliant, FDA-inspected GMP facilities. The company also provides expertise in plasma proteins, hemostasis, and blood coagulation and is a leading global supplier of coagulation research reagents (plasma proteins and antibodies), custom formulated IVD/POC device reagents, as well as customized blood collection tubes to support clinical trials. Visit us at goprolytix.com.

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