Quality Assurance Specialist

ABOUT MICROBAC

Microbac Laboratories, Inc. is a premier commercial laboratory testing firm that partners with clients worldwide, offering laboratory solutions to the life science, food and nutrition, and environmental industries and serves our clients with the utmost expertise and respect for their market requirements, constraints and challenges. We embody a company-wide commitment to exceptional customer experience, which has been refined over nearly 50 years of trusted, analytical and measurement experience.

Through our network of laboratories, offices, and field services, we have the flexibility to meet the unique requirements for each client, project and scope.

As a privately held third-party testing company, Microbac operates with a commitment to safety, quality and compliance. Our diverse work portfolio includes broad accreditation offerings and tested insights across the environmental, food and life science markets.

JOB SUMMARY

Under the direction of the Quality Assurance Manager, this position is primarily responsible to perform data review, assist with the development, implementation, and maintenance of the quality systems throughout the life science laboratory and oversee the audit program at our Wilson, North Carolina laboratory. Additionally, this position will helps to ensure that all relevant accreditations, licenses, and registrations are obtained and maintained.

ESSENTIAL FUNCTIONS

• Is responsible for the Quality Assurance review of data, validations, method transfers, equipment calibrations and/or qualifications, and other quality control data requirements.

• Serves as a liaison between operations and Quality Assurance while scheduling, conducting, and completing internal audits and supplier qualifications/re-qualifications for Manager's review in a timely manner.

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

•Performs internal laboratory audits and/or train others to perform internal laboratory audits base on internal documents and current accreditor and/or regulatory requirements.

•Performs supplier qualifications and requalification’s based on need, internal documents, and current accreditor and/or regulatory requirements.

*Performs verification of all corrections, corrective actions, and/or preventative actions based on internal documents and current accreditor and/or regulatory requirements.

•Reviews data for routine/stability testing, method qualification/validation, and instrument calibration/qualification as necessary.

•Maintains and updates both paper and/or electronic files as necessary to perform above stated functions, included but not limited to sending emails, creating memos, updating spreadsheet type documents. This may include included customer contacts and follow ups.

•Works as necessary to prioritize and complete projects on or ahead of schedule.

•Effectively and professionally communicates with all laboratory staff and management to create an environment of open communication, participation, and information sharing.

•Other job duties, such as special projects and special assignments, may be assigned from time to time at the discretion of Microbac.

MINIMUM REQUIREMENTS

▪At least an associate degree in applied science (2-year) with at least 5 years non-academic laboratory experience or bachelor (4-year) degree with at least 3 years non-academic laboratory experience.

▪Desired field of degree: Quality Assurance, Regulatory Affairs, Chemistry, Biology or a closely related field.

Job Requirements:

•General knowledge or awareness of 21 CFR Parts 11, 210, 211, and 820

•General knowledge or awareness of ICH Q7 and Q10.

•General knowledge or awareness of ISO/IEC 17025.

•General knowledge of analytical test methods for which data review is performed.

•Demonstrates leadership ability.

•Excellent communication skills, both oral and written.

•Detail orientated.

•Ability to work effectively with cross-functional teams and be part of a team.

•Use of both paper and electronic documents and files, including but not limited to Microsoft products, chromatography data systems, or other software

WORKING CONDITIONS AND PHYSICAL REQUIREMENTS

• The employee will regularly be exposed to an indoor office setting, as well as a commercial laboratory setting
• Reasonable accommodations will be made for those with disabilities

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status