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Quality Assurance Specialist

4 months ago

Winchester, United States BioIVT Full time

We are a leading global provider of high-quality biological specimens and value-added services. By combining technical expertise, exceptional customer service, and unparalleled access to biological specimens. Our mission is to provide high quality biological tissues, fluids, cell products, and services to our customers to further pharmaceutical research focused on bettering lives.

Our global team is made up of a diverse group of professionals committed to serving the needs of our 30,000 clients around the globe. Our culture’s core values consist of respect, integrity, accountability, communication, and quality. We operate in a fast-paced environment that, while in operation for over 30 years, maintains an entrepreneurial spirit and a “can do” attitude.


Position Description:

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.

This position will ensure compliance with Environmental Health and Safety (EHS) policies, State Departments of Health, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), EMEA and FDA Guidelines, general State and Country Regulations such as but not limited to (USP, ISO 9001, USDA regulations) where site appropriate.


Position Responsibilities:

  • 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.


Position 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.


Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be required to: stand; walk, sit, stoop, kneel, crouch, crawl, speak, hear/listen, smell, display manual dexterity, reach with hand and arms. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 30 pounds.


Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

While performing the duties of this job, the employee will be working in professional office environment using standard office equipment. While performing the duties of this job, frequently required to use personal protective equipment to prevent exposure to hazardous materials. The employee has potential for exposure to fumes, airborne particles and toxic or caustic chemicals, biohazards, flammable liquids, risk of radiation. The employee is occasionally required to use equipment with moving mechanical parts, with risk of electrical shock and vibration. The noise level in the work environment is usually moderate, at times, the noise level can be louder and hearing protection may be required. The employee may work both inside and outside in heat/cold, wet/humid, and dry/arid conditions

In addition to our vibrant and inclusive community, we offer a comprehensive package of competitive company-sponsored benefits, including healthcare, retirement plans, and more, ensuring the well-being of our employees and their families. We understand the importance of work-life balance, which is why we provide generous time-off policies to support your personal and professional needs. We embrace individuals of all backgrounds, experiences, and perspectives, and we're dedicated to creating a workplace where everyone feels valued, respected, and empowered to thrive.


We can’t wait to work with you


We are an equal opportunity employer.