Senior Quality Assurance Specialist
About the role
The Senior Quality Assurance Specialist will work closely with internal colleagues as a key member of the Quality Assurance team working to maintain and continuously improve Asuragen’s Quality Management System in alignment with international quality and regulatory standards.
Responsibilities
- Lead support for compliance with all regulatory standards, systems, procedures, and practices. Includes ISO 13485, FDA QMSR, MDSAP, IVDR, and other requirements relating to Quality Assurance activities.
- Execute QA production reviews, approvals and product release.
- Act as QA lead representative in new product design and development teams.
- Lead external audits, summarizing the results and providing summaries for Quality management.
- Execute Document Control, Training and QA Production related quality system activities.
- Lead the management of Training, NCR, CAPA, Complaints, Internal Audits, and Supplier Management quality systems. Responsible for the management of one or more of these systems.
- Reviews and approves validation activities.
- Reviews and approves controlled equipment calibrations and maintenance records.
- Support QA management in managing and driving Quality Objectives and Goals.
- Lead Quality Management Reviews. Identify and communicate risks to management with proposed mitigation plans.
- Create and conduct training for new QA team members.
- Other duties as assigned.
Qualifications
Education and Experience: Bachelor’s degree in a related field from an accredited four-year college or university & 7‑10 years of experience in a regulated manufacturing facility; or a combination of educational and applicable work experience. Master’s degree in a related field from an accredited four-year college or university 4‑6 years of experience in a regulated manufacturing facility; or a combination of educational and applicable work experience.
Knowledge, Skills, and Abilities: Skilled in the use of software programs such as Microsoft Office and database management programs. Detail oriented and skilled at examining documents for accuracy and completeness. Ability to prepare records in accordance with instructions. Knowledgeable in QA principles and concepts in a dynamic manufacturing facility. Ability to work in a fast paced environment. Ability to set priorities and meet deadlines on a personal level. Ability to work under tight deadlines. Capability to effectively train employees on procedures, processes, and QA concepts. Team oriented individuals with the ability to work effectively with multiple skill level employees. Skilled at dispute resolution. Excellent written and oral communication skills. Excellent analytical and problem-solving skills with the ability to work independently with minimal supervision. Familiarity with statistical tools and concepts and their application in a regulated environment. Ability to lead projects with cross functional teams. Ability to lead audits and reviews of processes. Knowledge of molecular science fundamentals, cGMP, ISO 13485, MDSAP, IVDD/IVDR and FDA QMSR preferred.
Benefits
- Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
- 401k plans, employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
- Mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs.
- Employee resource groups, volunteer paid time off, employee events, and charity drives.
- Accrued leave policy with paid holidays, paid time off, and paid parental leave.
- Culture of empowerment and innovation where employees feel valued and encouraged to bring new ideas.
Pay
Pay Range $78,100.00 - $128,500.00