Job Description
Growing small, flexible pharmaceutical company is looking for an experienced QA Specialist with quality assurance equipment and process qualification and validation experience to join their team on a contract to direct hire or direct hire basis in the Phoenix area near Sky Harbor. This is a Monday through Friday day shift. Benefits are provided during both contract and direct hire portions of the position.
Responsibilities include:
* Oversee and assist in development and implementation of quality validation and qualification system
* Assist with receiving operations & incoming raw material inspections and documentation.
* Assist with cleaning and sanitation operations are effective both visually and with ATP swabs.
* Assist with assurance that documentation of production operations is performed properly and securely.
* Assist with in-process batch documentation
* Assist with completed batch documentation and implement any corrective actions
* Assist with training of employees in current Good Manufacturing Practices (cGMP's)
* Assist in writing and approval of Standard Operating Procedures
* Assist with issuance and archive Standard Operating Procedures
Qualifications:
* Bachelor's Degree preferred, High School Diploma required - appropriate combination of education, training and experience will be considered
* Experience with development and implementation of validation and qualification is mandatory
* Experience in pharmaceutical manufacturing is mandatory
* Knowledge of FDA requirements (21 CFR 210 & 211) and Q7 Good Manufacturing Guidance for Active Pharmaceutical Ingredients
* Computer experience and proficiency (Excel, MS Word, other)