EMPLOYMENT

EMPLOYMENT

QA Specialist II

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 of analytical data for conformance to company and customer requirements.
  • Write and review 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.
  • Assist with the administration of the calibration program.
  • Schedule, review and sign off calibrations and equipment logs, along with the QA.
  • 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.
  • Works directly with operations, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner.
  • Monitors training compliance and conducts quality-related training.
  • Trains and mentors other Quality department staff to perform quality duties.
  • Conducts internal audits of departments involved in GMP activities and provides guidance for corrective actions.
  • Supports client and regulatory audits.

Requirements:

Qualifications include a Bachelor’s degree in a related science discipline with 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, 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.