Director of quality assurance
Location
Texas | United States
Job description
EPM Scientific is currently partnered with one of the nations fastest growing Pharmaceutical Manufacturing organizations who is currently going through a massive expansion at their cGMP facility based in Fort Worth, TX. Our client is eagerly seeking to add a Director of Quality Assurance to support some of the top pharma and biotech organizations in Texas, and nationally. This person will have the opportunity to continue building out an established quality team as well as push boundaries in quality transformations.
The preferred candidate should possess expertise in developing Quality Systems and a strong understanding of pertinent regulatory guidelines from agencies such as ICH, FDA, and 21CFR. On top of this, the preferred candidate should will experiences with smaller and/or start up Pharmaceutical Manufacturing Organizations.
Requirements:
- Perform quality audits for both developmental and commercial products. An ideal candidate will have experienced being the final point contact for the FDA during audits.
- Support all departments in creating documentation for the quality system, including SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, and change controls.
- Examine documentation related to batch, warehouse, metrology, engineering, and validation activities to verify their completeness and compliance with company policies, procedures, and cGMP requirements.
- Evaluate, authorize, and decline raw materials, packaging components, and crucial consumables for use in commercial manufacturing.
- Conduct line clearance and GMP monitoring tasks for pharmaceutical manufacturing and packaging processes.
Responsibilities:
- Bachelor’s degree in science or a technical discipline; advanced degree in Chemistry, Biology, or equivalent preferred.
- A minimum of 3-5 years of professional experience in Quality Assurance roles, including responsibilities such as inspection, auditing, and laboratory work.
- Robust understanding of Good Manufacturing Practices (GMP) and hands-on experience with current FDA regulations and requirements.
- Demonstrate an ability to work as part of a team and possess an excellent work ethic.
If interested, please apply directly in or email resume to [email protected]!
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