Manager Quality Assurance

Reporting to the General Manager, the Quality Assurance (QA) Manager is directly responsible for managing and coordinating all quality functions for the facility.

He/She maintains responsibility for all aspects connected with compliance, including the development, analysis and reporting of support data for regulatory agencies and Corporate Quality.

In addition, he/she is responsible for addressing all quality issues in a timely fashion and communicating that information to the site as required.

The Quality Assurance Manager is responsible to assure compliance with all corporate and government procedures and regulations and serves as the Management Representative and Responsible Engineering Manager for the facility.

Responsibilities


* Quality, Regulatory & Safety


* Maintains compliance with all regulatory requirements to include: FDA, OSHA, EPA, USDA and NRC as applicable.


* Actively pursues continuous process and quality improvement as measured by internal indices and external audits/reports.


* Coordinates activities relating to determining and reporting causes of non-conformances, as well as implementing corrective actions and process improvements; assist in appropriate retraining.


* Initiates and/or oversees change control process.


* Analysis of facility data for identification of trends and initiation of required actions.


* Coordinates all activities relevant to FDA, ISO, customer, Internal & other regulatory audits.


* Conducts internal compliance audits as required and maintains appropriate records.


* Maintains facility quality records and procedures.


* Coordinates and maintains personnel dosimetry records.


* Coordinates with plant Operations all system requalification activities as applicable.


* Assists Corporate Quality Assurance with special projects and assignments as requested.


* Coordinates facility management reviews.


* Coordinates and maintains facility risk analysis.


* Coordinates environmental monitoring and maintains personnel badge testing records.


* Executes Equivalency and Retrospective Revalidation studies/report where applicable.

Operations


* Coordinates/executes process validations and calibrations where required.


* Reviews and releases batch records for processed materials.


* Assists where necessary in establishing departmental objectives to meet overall facility goals.

Human Resources


* Communicates the company quality policy and values, motivating and sensitizing employees to the critical nature of our service.


* Involved in the hiring, retention, motivation and development of qualified personnel in QA/Validations positions, if applicable.


* Assists with new employee orientation, job function, GMP, safety and developmental training to employees as required by Standard Operating Procedures, Certification programs, corporate requirements and customer service initiatives.


* Interacts with all functions with...