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QA Specialist I

QA Specialist I

BA SciencesSalem, NH, US
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Quality Assurance Specialist

The Quality Assurance Specialist supports the QA Lead and the company's quality program by auditing analytical data, routine work, protocols and reports.

Primary Duties And Responsibilities

  • Review / release analytical data for conformance to regulatory, company, and customer requirements.
  • Alternate contact person for QA questions relating to laboratory operations and client correspondences.
  • Review laboratory protocols and reports for accuracy and compliance to cGMP's, as applicable.
  • Verifies data for GMP material (raw material, in-process, finished product, packaging, labeling and manufacturing components) was reviewed and approved by appropriate SMEs.
  • Review and approval of documents and data associated with the Stability Program.
  • Other assigned responsibilities as established by the Quality Assurance Lead.

Requirements & Qualifications

Qualifications include a Bachelor's degree in a related science discipline with 0-3 years of QA experience, preferably in a pharmaceutical industry.

Minimum Skills Requirements

  • Knowledge of GMPs related compliance regulations and guidance are required.
  • Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
  • A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
  • Must have excellent organizational, analytical, verbal communication and technical documentation skills.
  • Good computer skills, such as MS office software.
  • Must be a team player with integrity and concern for the quality of Company products, services and staff members.
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    Qa Specialist • Salem, NH, US