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.
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.