Senior QA Specialist

Job Description

Purpose of Position:

The Quality Assurance Senior Specialist will help provide leadership to the QA team in their daily completion of duties and work closely with Director, Quality to coordinate quality resources for product release and quality systems, as well as production and customer quality support.

Responsibilities and Duties:

Coordinate daily work within the Quality Assurance group to ensure efficient and effective document processing, testing review, product release and other required duties.

Administer a QA on the floor program then will provide risk-based facility and/or focused internal audits. Prepare audit reports and assure documentation with appropriate notification to management. Follow-up and coordinate with appropriate personnel for resolution to audit findings.

Administer the Deviation and Corrective Action/Preventative Action and Non-Conforming Materials programs. Perform complaint investigations and coordinate with other groups, as required, for resolution to quality issues.

Coordinate with required departments to assure appropriate prioritization of product processing and release to meet required timelines and customer needs.

Coordinate and review master and executed validation packages

Help make decisions regarding product releases based on product specifications and with appropriate additional justifications as required.

Serve as Master Control Doc Control Administrator for the applicable site as well as Corporate QA as needed, assuring documents are processed and updated appropriately. Provide training to staff on document handling within MasterControl as required.

Collect, compile and analyze product test data and other statistical quality data to assess areas for improvement in the quality system or in other process areas. Monitor tracking/trending of product quality data to support consistency in product quality and/or identification of potential issues. Submit monthly report with pertinent quality information and metrics to Director, Quality.

Participate in regular meetings with the Production team or other groups to review product results and/or resolve quality issues.

Work in conjunction with manager to develop required special departmental projects or implementation of continuous improvement programs.

Perform miscellaneous tasks or other duties as assigned by manager and supported by training, education or experience.

Can perform all duties listed in the Senior Quality Assurance Compliance Auditor job description.

Qualifications/Skills and Knowledge Requirements

Bachelor degree in a related scientific field with 5-7 years relevant experience or equivalent combination of education and experience.

3-5 years QA/QC/Production experience in the pharmaceutical or related industry (i.e. medical devices, biopharma, etc.) preferable. Familiarity with GMP, GLP or other related QA compliance systems.

Thorough understanding of process and product lines as well as cell culture best practices.

Thorough understanding of test methods and data calculations for business unit product line.

Very strong computer skills essential to include proficiency with word processing (Microsoft Word) and databases (Access and Excel). Advanced skills or additional proficiency with quality management software systems preferable.

Must be organized, show attention to detail and demonstrate good documentation practices.

Solid communication skills, both written and oral, and good writing and editing skills.

Exceptional teamwork and leadership skills.

Full-time