Quality Assurance 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
- 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.
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.