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. This is a full time position, working Sunday any 10 hours and Monday through Wednesday from 12:30-10:00.

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.