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
- 3-5 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 SST 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.
Recommended Jobs
Bar-back - Bethlehem Barrel & Drafthouse
The Barback is responsible for keeping inventory of transporting, stocking, and cleaning/clearing products. Perform tasks to support the bartender and other staff members. Assist with opening and clo…
HVAC Mechanical Engineer
Job Details: HVAC Mechanical Engineer My client is an MEP Consulting Engineering firm doing commercial, university , lab and other types of MEP projects. They are seeking a Mechanical Engineer…
Machinery Repair Technician
Drive Innovation in Product Maintenance with KIK Consumer Products Join a thriving team committed to compelling solutions in household and pool wellness products. At KIK, we believe in pushing bound…
FAC Lead
Job Title: FAC Lead Location: Cheswick, PA System One is looking for experienced FAC Lead for a nuclear outage at Susquehanna Steam Electric Station in Pennsylvania. Role will be involved in pla…
Senior Compounding Pharmacist
About us LifeMD is a leading digital healthcare company committed to expanding access to virtual care, pharmacy services, and diagnostics by making them more affordable and convenient for all. Foc…
Delivery Driver
Benefits we offer for Full-Time Employees: # Generous PTO (accrual of paid time off) # Competitive Compensation # Employee Discount Program # Health, Dental and Vision Insurance for Individuals…
J1 Family Medicine Outside of State College -School Loan Repayment - Outpatient only
Family Medicine opportunity for BE/BC family physician located in central Pennsylvania outside of State College, PA. Well established employer. M-F hours. You would treat pediatrics through seniors. …
Freelance Senior Project Manager
Company description What took you so long?! We've been waiting for you. Yep, you read that right. We are looking for you to bring your authentic self to work every day because we know that it's…
Production Manager - Snow Management/Landscape Maintenance
Major Areas of Focus Our Production Managers (PM) report to the Director of Operations of one of our Service Centers. PMs may oversee 3-5 Crew Leaders and their crew members. A Senior PM may be assig…
Senior Software Architect - Deep Learning and HPC Communications
Senior Software Architect - Deep Learning and HPC Communications page is loaded## Senior Software Architect - Deep Learning and HPC Communicationslocations: Switzerland, Remote: Poland, Remote: UK, R…