Manufacturing Associate I/II

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

Salary : $25 - $33