Quality Assurance Specialist

Key Responsibilities:

· Facilitate QA Strategy implementation, delegated GxP inspection readiness efforts, providing Quality Assurance Unit support as described in 21 CFR Part 58, providing metrics tracking and reporting.

· Perform audits on raw data and final reports to assure accuracy and compliance with GxP, study protocols, and laboratory procedures.

· Monitor laboratory quality assurance activities to determine conformance with authorized policies and procedures and with sound practice.

· Review all documentation for adherence to organizational quality standards.

· Ensure that facilities, equipment, organization, processes, and procedures comply with applicable regulations and company standards.

· Provide QA support of change controls, deviations, investigations, CAPA’s and effectiveness checks.

· Develop and maintain compliance-related trending metrics and reports.

· Makes appropriate recommendations for correction and improvement as may be necessary.

· Provide oversight of personnel training record management.

· Provide QA support of internal and external audits, as assigned.

· Reviews and updates Quality Assurance procedures.

· Maintains audit forms and QA records.

· Other duties as needed.

Qualifications:

· Bachelor’s degree in quality assurance or science-related field.

· Minimum of 5 years in GxP or equivalent regulatory environment.

· Excellent knowledge of GLP and GCP requirements.

· Working knowledge of ISO 9001, ISO 17025, and ISO 17034.

· Experience with reviewing laboratory data and computer validated data collection systems in a preclinical and clinical environment.

· Able to understand published methodology to audit existing test methods and ensure accuracy.

· Thorough understanding of governing regulations and pertinent scientific literature to ensure compliance.

· Experience performing quality process audits and review of deviations and CAPA.

· Solid working knowledge of Microsoft Office software (e.g., Excel, Word, PowerPoint).

· Possess excellent time and project management skills, being able to manage and prioritize multiple tasks under strict deadlines with minimal supervision.

· Possess excellent interpersonal skills, being able to consult and work with multi-disciplined teams.

· Possess excellent verbal and written communication skills, including the ability to understand and verify scientific text and data.

· Background in molecular biology, virology and/or serology is a plus.

· Contract research organization (CRO) experience is a plus.

· Experience with eQMS (Qualio) is a plus.

Job Type: Full-time

Pay: $70,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Referral program

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Application Question(s):

• Do you have Experience with ISO 9001 or other quality management systems?
• Do you have experience in contract service organization (CRO), Biotech, BioPharma?
• Do you have Experience in change controls, deviations and CAPA investigation?

Education:

• Bachelor's (Preferred)

Experience:

• Quality assurance: 5 years (Required)

Work Location: In person