The QC Manufacturing Associate works in a team based environment to perform all tasks related to the qualification of gel electrophoresis products. The hours for this role will be predominantly 2nd shift work. Flexibility to fit production requirements will be necessary.
Key Objectives of the role:
- Quality Control Testing for the production of protein analysis tools
- Responsible for qualifying product(s) in a lab setting following standard operating procedures. Will utilize basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture and qualify products.
- Complete all batch records and manufacturing documents according to quality systems standards as required
- Verbal or written communication of problems to manufacturing leadership and assistance in identifying variables and offering resolutions
- Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure within operating parameters. Advise manager of factors that may affect quality of product. Suggest options/ideas for corrective actions.
- Keep manufacturing leadership informed of the status of assigned QC processes
- Carry out Standard Operating Procedures involved in high throughput manufacturing, visual inspection, material handling and inventory control
- Operate semi-automated equipment in the production of protein analysis tools
- Train other team members on techniques and processes
- Interact daily with equivalent levels of personnel in the manufacturing area
- Attend trainings or read content to understand and follow applicable manufacturing processes and Standard Operating Procedures
- Accuracy and attention to detail is required in performing all functions of this position; errors in work could cause delays in production schedules.
- All other reasonable tasks as may be requested by the Team Leader and/or the Production Supervisor.
- Bachelor’s degree in Biology, Molecular Biology, Biochemistry, Biotechnology or other related discipline -OR- 2+ years of experience in a manufacturing or research laboratory
- Experience in ISO or cGMP regulated manufacturing environment.
- Excellent documentation and communication skills.
- Must be able to work safely with chemicals and hazardous materials.
- Must be flexible to work varying schedules and hours as needed.
- Ability to perform measurements and dilutions of material
- Ability to handle and dispose of hazardous materials
- Must be able to lift 40 lbs. or 20 lbs. repetitively throughout the day
- Must be able to stand for an extended period of time
- Must be able to wear a respirator as needed
- Ability to operate within generally defined procedures and practices under general direction and minimal supervision.
- Excellent oral and written communication skills are required.
- Must be able to work with numerous departments and varying levels of employees.
- Requires extensive knowledge of manufacturing processes and inter-departmental responsibilities.
- Must demonstrate ability to work with internal and external customers.
- Demonstrates strong leadership and supervisory skills.
- Working knowledge of Microsoft Excel and MS Word is required.
- Working knowledge of MRP system.
- Consistent, dependable and accurate in carrying out responsibilities.
- Displays positive attitude toward job and others.
- Maintains personal composure in high stress situations.
- Maintains confidentiality.