Quality Assurance Systems & Project Specialist

Forest Pharmaceuticals, Inc. is an international manufacturer and packager of solid dosage and liquid pharmaceutical products and has been ranked by Pharmaceutical Executive as one of the top 50 pharmaceutical companies for the last three years. The Cincinnati facility is searching for qualified candidates to fill the following position:

Quality Assurance Systems & Project Specialist

This position will be an integral part of Forest’s Quality Assurance team, charged with establishing and ensuring effective and compliant Quality Systems. The responsibilities of this position will include but are not limited to:

- Coordinate Corrective Action / Preventative Action (CAPA) program. Maintain records demonstrating completion of CAPA and follow up with department heads on outstanding CAPA commitments. Submit periodic reports to management including quality metrics on CAPAs.
- Provide technical and data retrieval support for site projects and investigations.
- Design new and improve existing Quality Systems.
- Support the implementation of Corporate Quality Standards and Policies.
- Manage assigned projects from implementation through completion.
- Administer GMP documentation for incoming material.
- Collect and tabulate data for Annual Product Reviews. Evaluate data and prepare Annual Product Reviews for packaged product.
- Review temperature, humidity records and evaluates excursions.
- Work with QA Supervisor to ensure proper filing systems for all GMP related records / documentation. Control access to allow for adequate security while provide for prompt record retrieval and return.
- Coordinate proper archival and destruction of GMP related records / documents.
- Assist in various QA department responsibilities such as Batch Production Record issuance and audit executed record, customer complaint investigations, GMP and SOP training, and Annual Product Reviews.
REQUIREMENTS
Qualified candidates must possess a Bachelor’s degree in a scientific discipline with a preferred two to four years experience in pharmaceutical manufacturing or FDA regulated industry. Applicant must have the ability to multi-task and possess strong organizational and communication skills. The position requires proficiency in basic mathematics, statistics, and ability to interpret written instruction and data. Proficient in the use of various software including MS Word, Excel, Access, Powerpoint and Explorer preferred.

Forest offers a competitive salary and comprehensive benefits plan including medical, dental, and life insurance. Our benefits also include profit sharing and 401(k) plans, short-term disability and educational assistance. For more information on Forest Pharmaceuticals and Forest Laboratories, please visit www.frx.com.

Qualified Applicants should send cover letter, resume and salary history to: [Click here for email], EOE