Quality Specialist - Pharma, QA, Validation



Advert ID




Job Type




Salary Range

Up to USD0.00 per year

No. of Openings


Branch Information

Phoenix Engineering - (USA) 7025 North Scottsdale Road Suite 170 AZ Scottsdale , AZ 85253



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


* 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)