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EMPLOYMENT

EMPLOYMENT

Quality Assurance Specialist

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

Primary Duties and Responsibilities:

  • Review/release routine project folders for conformance to regulatory, company, and customer requirements.
  • Review and approve Standard Operating Procedures (SOP’s, Forms and Methods) and familiarity with internal SOPs.
  • Alternate contact person for QA questions relating to laboratory operations.
  • Review laboratory protocols and reports for accuracy and compliance to cGMP’s, as applicable.
  • Review and approval of data for determining the disposition of GMP material (raw material, in-process, finished product, packaging, labeling and manufacturing components) and the review and approval of documents and data associated with the Stability Program.
  • Other assigned responsibilities as established by the Quality Assurance Lead.

Requirements:

Qualifications include a Bachelor’s degree in a related science discipline with 0-1 years of QA experience, preferably in a pharmaceutical industry.

Minimum Skills Requirements:

  • Knowledge of GMPs related compliance regulations and guidances 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.