Job Description
JOB TITLE: QC/QA Incoming and Release Specialist
DEPARTMENT: Quality Assurance
POSITION REPORTS TO: QA Manager
BASIC PURPOSE OF POSITION:
Provide QC receiving and inspection support for the organization. This position is responsible for reviewing controlled documents for accuracy, completeness and in accordance with cGMP, GDP, related company SOPs, State and Federal laws prior to and including sterilization, testing, and release of product. Provide Quality Assurance support to all areas of product development and production. This is a high-energy position that requires the ability to organize, prioritize and work with a sense of urgency and positive attitude.
ESSENTIAL FUNCTIONS/DUTIES:
- Responsible to disposition (approve/reject) all finished product/devices and review production records to assure that no error has occurred.
- Report errors found in the respective batch record/shop order to manufacturing and ensure correction and/or resolution.
- Generation of Certificates of Analysis and Certificates of Compliance to be included with shipments of the finished product/device.
- Enter/update production lot data into various Excel spreadsheets.
- Creation of purchase orders and close out of batch records/shop orders.
- Responsible for controlling and filing (by lot number and date) all original production records.
- Apply good documentation (GDP) and understanding of good manufacturing practices (cGMP) to ensure documents meet the acceptance criteria.
- Ensure QA test samples are forwarded to the lab for testing and review test results for acceptability.
- Ability to identify a problem and offer a resolution to avoid major issues.
- Work independently and ensure all documents tied to product release are prioritized appropriately.
- Exceptional attention to detail and ability to maintain consistency.
- Complete special projects assigned by Quality Management.
- Display a willingness to learn and assist in other department activities when needed.
- Able to lift/move up to 25lbs and walk and/or stand for long periods of time.
- Flexibility to work hours between 7:00am – 6:00pm.
- Maintain good attendance according to company policy.
- Complete incoming QC inspection of material per ALCOA requirements.
- Ability to record measurements and ensure compliance with receiving specifications per material received.
- Ability to use proper sampling techniques and equipment dependent on material received.
KEY WORKING RELATIONSHIPS:
- INTERNAL: Must be able to work as part of an interdisciplinary team, interacting easily with the members of the team and providing consultation to other personnel in a positive, supportive way.
- EXTERNAL: Must be able to communicate and interact with external vendors.
SUPERVISORY RESPONSIBILITIES:
- Ability to supervise the work of support personnel, if required.
EDUCATION AND EXPERIENCE REQUIREMENTS:
- Minimum of 3 years of progressive experience in Quality Assurance within cGMP environment, preferably pharmaceuticals and/or medical device industry.
- Knowledge and use of Outlook, Word, and Excel.
- Knowledge and use of QMS software a plus.
PREFERRED QUALIFICATIONS AND SKILLS:
- Familiarity ISO 13485 Regulations, FDA, GMP and QSR requirements.
- Very proficient in attention to detail.
- Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
- Ability to work in collaborative and independent work situations.
- Ability to remain calm and receptive in fast paced situations.
Job Type: Full-time
Pay: From $50,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
