Quality Assurance Specialist

1 week ago

Watertown, Massachusetts, United States Sequoia Biotech Consulting Full time
Job Title: Quality Assurance Specialist

Sequoia Biotech Consulting is seeking a seasoned Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for managing, administering, developing, and delivering quality programs and oversight with various therapeutic products within the life sciences industry.

Key Responsibilities:
  • Lead and/or support the development of supplier audit program, including planning, execution, risk mitigation and close out of planned external audits or assessments.
  • Liaise with Supplier Quality Program stakeholders to coordinate and prioritize the completion of external audits.
  • Communicate with and monitor external supplier compliance to audits, quality agreements, and corrective actions.
  • Monitor, update and report on external audit program metrics.
Additional Responsibilities:
  • Support hosting client audits and regulatory health authority inspections.
  • Compile and provide operational and quality metrics for periodic Management review.
  • Promote a Quality Culture by driving continuous improvement, innovation, teamwork and efficiency.
  • Perform Quality systems element assessments/audits to identify deficiencies in processes and procedures according to client quality and regulatory standards and guidance.
  • Establish core quality programs, oversight and controls for Document Management, Change Management, Deviation/Investigation Management, and Training Management.
  • Provide expert technical and operational support for resolving quality deficiencies and remediation activities.
  • Prepare clients for audit readiness, risk management and mitigation, and review of quality procedures, documentation, and records.
  • Perform risk assessment for cGMP compliance and functional risk programs.
  • Lead and provide Quality review, certification and management of batch records and work orders to ensure compliance with SOPs and cGMPs for lot release and disposition.
  • Participate in the development, implementation, and maintenance of the company's quality management systems.
  • Lead investigations and activities for a variety of non-conformances which may include deviations, CAPA, OOT, AA, or OOS activities.
  • Gather information/data, prepare investigation reports, and shape corrective/preventive actions to resolve recurring problems with permanent solutions.
  • Support audit readiness and pre-approval inspection (PAI) readiness of internal and external systems.
  • Provide assistance in preparation and during regulatory inspections, due diligence audits, serving as QA escort when needed.
  • Create, review and maintain quality records/metrics and make process improvement recommendations to management.
Requirements:
  • Bachelor's degree within a life science or related field required.
  • 8-13 years of experience within Pharma/Biopharma, Medical Device, or Diagnostics industry.
  • Preferred certifications: ASQ, ISO standards for auditing including 13485, ISO 9001, ISO 14971.
  • Extensive experience working with and leading Quality for various products in support of clinical/commercial manufacturing.
  • Experience in the application of Quality Assurance principles, concepts, industry practices, and standards.
  • Knowledge of cGMP standards, FDA regulations, US standards 21CFR210, 21CFR211, 21CFR11, 21CFR820, ICH Quality Guidelines, Quality System Regulations and ISO standards including 13485, ISO 9001, ISO 14971.
  • Significant experience with a variety of software including MS Office; Project, Visio, LIMS, and EDMS.
  • Excellent communication and leadership skills as well as a strong work ethic.
What We Offer:
  • Excellent healthcare options: Medical, vision, prescription & dental.
  • Family Focus & Balance: Parental leave, flexible time-off and Employee Assistance Program.
  • Financial Security: 401(k) with employer matching.
  • Tuition Reimbursement: Continuing education for every season of your career.
  • Employee Recognition Programs.
Compensation:

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $106,991.88/year in our lowest geographic market up to $152,382.37/year in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

Legal Statement:

Sequoia Biotech provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.

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