Manufacturing Associate I/II
1 month ago
Job Title: Manufacturing Associate I/II
Reports to: Director of Manufacturing
Functional Area: Manufacturing
Responsibilities:
· Perform manufacturing of medical device products following cGMP guidelines, adhering to work instructions and standard operating procedures.
· Schedule manufacturing tasks under cGMP guidelines under supervision of manufacturing director.
· Accurately complete documentation, including batch records and logbooks.
· Perform all responsibilities necessary to validate, operate, troubleshoot, and maintain equipment.
· Reliably executes and writes well defined SOP’s and manufacturing records. Initiates and writes revisions to current protocols using GMP/SOP guidelines and document change system.
· Initiating and closing deviations, investigations and CAPAs of moderate complexity.
· Maintain appropriate inventory levels of raw materials and supply items used in manufacturing.
· Perform administrative duties, routine cleaning, housekeeping and non-routine maintenance.
· Adhering to strict regulatory compliance with procedures according to the roles and responsibilities.
· Acceptance of other duties as assigned.
Education and Experience:
· Associates Degree required. Bachelors degree in scientific discipline preferred.
· 1-3 years of experience working in a GMP controlled environment or equivalent combination of education and experience.
· Basic working knowledge of Microsoft Word and Excel
Competencies & Skills:
· Ability to work in a fast-paced controlled cleanroom environment up to 8 hours a day with additional overtime as required
· Exceptional attention to detail and passion for problem-solving with a developed sense of ownership and responsibility
· Ability to use PPE (Personal Protective Equipment) and understand chemical hygiene
· Ability to use hand tools and equipment including forceful gripping, grasping, pushing, pulling and repetitive motion
· Ability to multi-task, be flexible and handle changing priorities
· Strong interpersonal skills with a demonstrated ability to work independently as well as in a team environment
Job Type: Full-time
Pay: $25.00 - $33.00 per hour
Expected hours: 40 per week
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Retirement plan
- Vision insurance
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