What are the responsibilities and job description for the Quality Technician position at Prosidyan, Inc.?
Prosidyan is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass.
The Quality Technician will participate in and support Quality Control and Quality Assurance activities in accordance with Prosidyan quality system processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Participate in CAPA, document control, supplier quality, disposition and investigation of nonconforming materials, customer complaints, internal audits and DHR review in accordance with quality assurance procedures.
- Perform incoming product inspection and support product release activities.
- Interact with vendors or possible vendors to undertake testing and /or obtain cost estimates.
- Collect manufacturing, shipping, sterilization and packaging data.
- Support performing various product and packaging tests, shelf life studies.
- Co-ordinate with operations to maintain accurate product inventory.
- Assist as necessary in the completion of documentation for Design Control documents and Technical reports.
- Understand and follow all procedures/work instructions and Good Manufacturing Practices including those that outline safety, cleanliness, calibration, assembly/process specifications, proper labeling, etc.
- All manufacturing and quality records/documents must be completed accurately and in accordance with Good Documentation Practices.
- All directions and instructions must be followed and must be able to work in a focused team environment.
- Must maintain a high degree of quality in all work performed
- Responsible for compliance with quality system procedures and all regulatory requirements.
Education, skills and Experience:
- High School diploma or equivalent. Degree in a related science a plus. Combination of education and experience in related field of medical device/ pharmaceutical industry will be considered.
- 1-3 years experience in medical device/pharmaceutical industry in QA or QC role supporting GMP activities
- Demonstrated knowledge of cGMP’s
- Good computer skills with experience with Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations is required.
- Strong attention to detail and good communication skills.
- Flexible and able to respond quickly to shifting priorities and meet deadlines.
- Authorization to work in US indefinitely without restriction, sponsorship or VISA transfer.
Prosidyan, Inc. is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Application Question(s):
- Are you authorized to work in US indefinitely without restriction or sponsorship.
Experience:
- medical device/pharma QA or QC: 1 year (Preferred)
Work Location: One location