Senior QA Specialist

BioIVT is a leading global provider of research models and valueadded research services for drug discovery and development. We specialize in control and diseasestate biospecimens including human and animal tissues cell products blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research aiming to improve patient outcomes by coupling comprehensive clinical data with donor samples. As the premier supplier of hepatic products including hepatocytes and subcellular fractions BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes. By combining our technical expertise exceptional customer service and unparalleled access to biological specimens BioIVT serves the research community as a trusted partner in elevating science

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 Sr. 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 riskbased facility and/or focused internal audits. Prepare audit reports and assure documentation with appropriate notification to management. Followup and coordinate with appropriate personnel for resolution to audit findings.

Administer the Deviation and Corrective Action/Preventative Action and NonConforming 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 Batch Record 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 Sr. 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.

Team lead responsibilities; providing general guidance site Quality decision making and direction to Baltimore QA team members supporting the broader Baltimore QA team and Sr. Director.

Qualifications/Skills and Knowledge Requirements

Bachelor degree in a related scientific field with 57 years relevant experience or equivalent combination of education and experience.

35 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.

We offer a comprehensive benefit package for eligible team members including medical dental vision shortterm/longterm disability life insurance hospital indemnity and accident insurance. We also provide a generous retirement plan with a company match. Eligible employees enjoy competitive timeoff policies and a collaborative environment that promotes growth from within. Enjoy companysponsored events for the entire team!

Join Us!

We cant wait to work with you! At BioIVT we believe that diversity and inclusion are key drivers of innovation and success. We are committed to creating a workplace where everyone feels valued respected and empowered to bring their unique perspectives to the table. We seek to build a diverse team and encourage applications from people of all backgrounds experiences and identities.

To Learn more about our mission and team culture click here!

BioIVT is an equal opportunity employer. We celebrate diversity and are dedicated to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status protected veteran status or any other characteristic protected by law.