Job Details

HIRING Quality Assurance Specialist! Medix Life Sciences is the fastest growing staffing organization specializing in Clinical Research and Life Sciences placements for all the major health systems and research organizations throughout the country. Medix is looking for an candidate with a BS degree and 5+ years of GMP/FDA Quality experience

Requirements:

• Degree: BS degree
• Years of Exp: 5+ years of GMP/FDA Quality experience (prefer pharmaceutical industry but open to food or medical device)

Position Summary: Location: Houston, TX 77054 Pay: 75-85k depending on experience Hours: M-F business hours Duration: Direct Hire

Position Description:

The Quality Assurance (QA) Specialist is responsible for ensuring the quality and safety of products produced through the manufacturing processes. The QA Specialist will assist in the development, implementation, and maintenance of the quality assurance procedures and standards.

Heavy documentation role.

Creation and revision of SOPs and other GMP records.

GMP documents control and record keeping.

Review and approval of GMP documents from a quality standpoint.

Oversight for compliance of Change Controls, CAPA and investigations, OOS and deviations.

Support manufacturing operations to address compliance related concerns.

The role might eventually require aseptic gowning and clean room presence(<10% of the time)

Experience in creating SOPs and batch records.

Experience in doing review of GMP documents.

Knowledge of GMP and Quality Systems regulations (21CFR Part 11, 210, 211, 820)

Knowledge of aseptic operations.

Must have strong attention to detail.

Solid written/verbal communication and organizational skills.

Strong Microsoft Office skills (Word, Excel)

Qualified candidates are encouraged to apply! We would love to discuss these positions with you further!