Quality Assurance Specialist
- Review, approve, and document batch records and release of product
- Administration and of all QMS documentation
- Document Control and Training SME and electronic QMS (e.g., Grand Avenue) administrator
- Implement, review, and facilitate investigations including Corrective and Preventive Actions (CAPA)
- Assist with and/or lead investigation and resolution of customer complaints
- Assist in and/or lead the management of change controls/ECOs and associated activities
- Lead Material Review Board meetings and facilitate material and documentation dispositions as needed
- Communicate deficiencies and/or compliance issues to QA/RA management
- Responsible for driving goals and initiatives for continuous improvement of procedures, processes, and systems
- Compile data and report QMS metrics as required
- Administer and deliver Quality Assurance training
- Coordinate and perform audits (internal, process) as required
- Support and organize audit preparation and performance activities
- Support testing and release activities for Quality Control (QC)
- Bachelor’s degree in a Scientific or Life Science field or equivalent work experience
- 1-3 years’ experience in a Quality function under ISO 13485, experience with QMS documentation and Good Document Practices and/or internal/lead auditor experience preferred
- External certification, (CQA, CQE, RAC, etc.) preferred, or at a minimum, a clear path to achievement through advanced degrees or training
- Excellent technical writing skills with great proficiency in spelling, grammar, formatting, and completeness of documentation
- Analytical approach to problem solving; critical thinker
- Prior experience with eQMS systems preferred
- Proficiency with Microsoft Word, Excel, Outlook, and PowerPoint
- Ability to work proficiently and independently in a regulated manufacturing setting lab related experience a plus
- Independent, initiative-taker; able to complete assigned tasks in a timely manner with minimal day-to-day direction; k een diligence and ability to follow directions
- Ability to effectively present and lead in formal, one-on-one, and group situations
- Strong people skills and ability to work with others in a positive and collaborative manner
- Organized with ability to identify and manage priorities; reliable follow-up and follow-through as needed
- Ability to follow and adhere to all Safety guidelines and processes including PPE as required.
Physical Demands: Stooping, turning, bending, squatting, kneeling and the ability to lift to thirty pounds, ability to reach to seven feet unassisted; constant/repetitive standing; requires normal, correctable vision and hearing, and the ability to accurately discern color as necessary to perform job functions.
This position may require regular and sustained laboratory time around chemicals which may be hazardous and may work within a Class 7 cleanroom for periods of time. What Biocoat Offers:
- Competitive salary, eligible for a discretionary bonus
- Benefits (medical with HSA component, dental, vision, critical illness, and accident insurance)
- Life insurance, short- and long-term disability paid by the company
- Flexible Spending Accounts (FSAs)
- 401(k) plan with an immediate company match
- Paid time off
- Education Assistance Program
- Rewards and Recognition Program
- Parental Leave
- Employee Assistance Program
- Additional benefits such as the opportunity to leave early on Friday's, business casual dress, friendly work environment, and fun company events.
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