What are the responsibilities and job description for the Quality Assurance Specialist position at Masis Professional Group?
QA Specialist
Our client is a specialist in the field of molecular imaging and nuclear medicine supplying different radiopharmaceuticals, radiochemicals and related equipment for the synthesis and quality control of PET/SPECT tracers and other radioisotopes.
This person develops and helps manages the QA system in a regulated radiopharmaceutical environment with regards to U.S. FDA cGMP and international regulations. This person assists in all activities to verify that appropriate, current procedures are followed, and keeps the General Manager and other designates fully informed, through verbal and written reports on the status of QA projects. This person also manages deviations, Out-of-Specification results, change control requests, customer complaints, customer and internal audits, regulatory authorities’ inspections, training of personnel and certifications for the Wilmington facility. This person organizes and promotes company-wide quality improvement efforts as well as being responsible for administering the Corrective/Preventive Action program.
Duties
- Develops the QA system under the guidance of the General Manager and in coordination with Radiopharma GmbH located in Germany.
- Authors, reviews, and approves of Standard Operating Procedures (SOPs) and further cGMP documents.
- Assures compliance with the company Quality Assurance systems.
- Maintains files on current suppliers, training programs and the audit/inspection results.
- Maintains approved supplier qualification program.
- Provides QA support for product development.
- Performs and reviews/approves design control and risk management activities associated with products under development.
- Works closely with the research and development team to ensure potential product issues are identified and addressed in design.
- Reviews and approves manufacturing and packaging batch records, as well as analytical results associated with commercial products as needed.
- Supports the production team and the quality unit with authoring and reviewing of documents, performance of qualification and validation activities.
- Performs 3rd party contractor and consultant management activities such as review of design control deliverables, assessment of supplier changes, supplier controls (corrective actions), quality agreements, relationship developments, etc.
- Provides support in review of Quality Agreements with external customers and suppliers.
- Conducts compliance and due diligence audits with 3rd party contractors and consultants as needed.
- Ensures compliance with corporate and regulatory agency requirements for radiopharmaceuticals as appropriate.
- Represents the company during internal and external audits, and regulatory authorities’ inspections.
Requirements
- Bachelor’s degree in a scientific or related field.
- 3 years’ experience in Quality Assurance of Drug Products, Good Manufacturing Practice (cGMP) and FDA inspection, manufacturing, or quality unit.
- Excellent communication, verbal, and writing skills.
- Excellent planning, organization, and flexibility to adjust to a rapidly changing environment.
- Strong attention to detail
- Ability to work independently and in a team environment.
- Must have professional and cooperative attitude
- Qualified as an Internal Auditor will be an advantage.
- Proficient in Microsoft Excel, Word, and Access
- Able to lift to 50 lbs.
Job Type: Full-time
Pay: $75,000.00 - $95,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Retirement plan
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Supplemental Pay:
- Bonus pay
Work Location: One location
