Senior QA Specialist

BioIVT is a leading global provider of high-quality biological specimens and value-added services. The company specializes in control and disease state samples including human and animal tissues, cell products, blood, and other biofluids. BioIVT's unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples and specialized ADME-Tox and drug transporter research services.

The Quality Assurance Senior Specialist will help provide leadership to the QA team in their daily completion of duties and work closely with Senior Director, Quality or Quality Leadership to coordinate quality resources for internal teams, as well as provide oversight to the QMS.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• 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 Customer Complaints, 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.
• Help make decisions regarding product releases based on product specifications and with appropriate additional justifications 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 Senior 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.
• Be the local subject matter expert for compliance matters at the site where hired.
• Perform miscellaneous tasks or other duties as assigned by manager and supported by training, education or experience.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

• Bachelor degree in a related scientific field with 4-6 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.

Other Skills and Abilities

• 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
• Proficiency in MasterControl is preferred but not required.

We offer a comprehensive benefit package for eligible team members including medical, dental, vision, short-term/long-term disability, life insurance, hospital indemnity and accident insurance. We also offer a generous retirement plan with a company match. Eligible employees also enjoy competitive time-off policies. We are a collaborative environment that promotes growth from within. Enjoy company-sponsored events for the entire team!

We can't wait to work with you!

We are an equal opportunity employer.