EMPLOYMENT

EMPLOYMENT

QA Specialist – All Levels

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

    • Auditing chemists’ routine project folders for conformance to company and customer requirements.
    • Write, review and edit Standard Operating Procedures (SOP’s, Forms and Methods) and familiarity with internal SOPs.
    • Alternate contact person for QA questions relating to laboratory operations and client correspondences.
    • Work with area management on the writing, issuance and tracking of deviations and investigations for closure.
    • Perform and assist with GMP audits.
    • Review and approval of Standard Operating Procedures, Specifications, Deviation Reports, Change Controls, and supporting documentation.
    • 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:

Qualification include a Bachelor’s degree in a related science discipline with 0-3 years of QA experience, preferably in a pharmaceutical industry.  Experience in a regulated industry. Experience writing and reviewing SOPs, QC data and documentation. Knowledge of LIMS a plus. Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with biotechnological, parenteral drug manufacture and/or medical device production.

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.