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
- 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 & Qualifications:
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.