Job Description
Job DescriptionSalary:
JOB SUMMARY
The Quality Assurance Specialist supports the QA Lead and the companys quality program by auditing analytical data, routine work, protocols and reports.
PRIMARY DUTIES AND RESPONSIBILITIES
- Review/release analytical data for conformance to regulatory, company, and customer requirements.
- Alternate contact person for QA questions relating to laboratory operations and client correspondences.
- Review laboratory protocols and reports for accuracy and compliance to cGMPs, as applicable.
- Verifies data for GMP material (raw material, in-process, finished product, packaging, labeling and manufacturing components) was reviewed and approved by appropriate SMEs.
- Review and approval of documents and data associated with the Stability Program.
- Other assigned responsibilities as established by the Quality Assurance Lead.
REQUIREMENTS & QUALIFICATIONS
Qualifications include a Bachelors degree in a related science discipline with 0-3 years of QA experience, preferably in a pharmaceutical industry.
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.