Quality Specialist I in Bedford

Under general supervision, this position is responsible for applying standard procedures to ensure test results, including the quality of cGMP laboratory testing processes, are met for final approval and release to laboratory customers. Applies quality methodologies to ensure required outcomes.

Duties and responsibilities regularly performed by and assigned to Quality Specialist levels I, II, and III:

• Reviews and approves quality control and verifications for the routine testing of biological samples. Ensures thorough test batch review and verifies that all source data meets quality attributes and cGMP regulation conformance prior to result reporting.
• Approves final test results for release to laboratory customers.
• Maintains accurate records and documentation as required by established procedures and good documentation practice regulations. Ensures donor, patient, and employee confidentiality.
• Supports the archival record organization and classification maintenance process. Ensures standard operating procedures (SOPs) are properly followed.
• Partners with personnel from various departments. Resolves routine problems by following SOPs and escalates as appropriate.
• Analyzes environmental monitoring. Assists with problem investigations and ensures any temperature and/or humidity issues are addressed.
• May review equipment re-qualifications and release instrumentation back into the production environment.
• May review and approve general laboratory equipment calibrations and verifications and ensure acceptance criteria are met.
• May review and approve critical testing reagents for use in production. Assists with lot changes as directed.
• May pack and ship supplies and/or specimens.
• Participates in performance improvement teams and training programs, as required.
• Assures quality customer service to all customers.
• Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
• Maintains good attendance and punctuality per the absence policy.
• Performs all other duties, at the discretion of management, as assigned.

Additional duties and responsibilities regularly performed by and assigned to Quality Specialist levels II and III:

• Maintains test batches and results in the laboratory information system.
• Completes constructive investigations and resolves batch review discrepancies.
• Serves as a resource for moderate complexity corrections and/or clarifications.
• Provides mentorship, guidance, and training to newer staff.
• Assists with internal and external audits.
• May coordinate data collection and evaluation of un-assayed control lots for release.

Additional duties and responsibilities regularly performed by and assigned to Quality Specialist level IIIs:

• Performs responsibilities with minimal instruction for day-to-day operations.
• Provides advanced cross-departmental and/or cross-site support.
• Analyzes testing and QC data to identify and/or investigate trends.
• Resolves a wide range of complex quality and production problems to ensure test results meet all quality attributes prior to release.
• Assists with workflow coordination.
• Assists with establishing quality standards for new work practices as required.
• Assists with investigating and completing CAPA associated deviations.
• Maintains working knowledge of assay processes performed at the laboratory.
• May coordinate laboratory proficiency and blind sample challenges.

Education: Bachelor's degree required.

Experience: + Quality Specialist II: A minimum of 2 years of professional experience working in a cGMP regulated environment required. + Quality Specialist III: A minimum of 4 years of professional experience working in a cGMP regulated environment, to include previous training experience and comprehensive understanding of laboratory production processes required.

Bachelor's in biology, chemistry, or other science related degree preferred.

Previous experience with adult training concepts and their applications.

Trainer Certification preferred.

Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.

Must possess strong critical thinking and problem-solving skills.

Must be able to maintain confidentiality.

Must have proficient computer skills.

Must be knowledgeable in computer operation in a Windows environment and able to follow company procedures to resolve issues.

Ability to work in a team environment and participate as an active team member.

Must be able to understand, follow, and give precise written and verbal instructions, and perform all activities safely.

Must be able to read and comprehend written procedures and instructions.

Lab work environment: Exposure to biological fluids with potential exposure to infectious organisms. Exposure to extreme cold (≤ -20[0]C), miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on the production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Specific vision abilities required by this job include close vision, distance, colour, peripheral vision, depth perception and the ability to adjust focus.

Travel: