Responsible for performance of technical tasks in specific areas of manufacturing operation as defined by the Director of Operations. Operates in conjunction with supervisor to meet area priorities. Daily operations must follow all FDA QSR guidelines as well as safety and environmental regulations.
Specific Functions and Responsibilities:
- Performs tasks in manufacturing, inventory control and distribution.
- Provides feed back to the Manufacturing Supervisor as to the status of operations.
- Manage inventory of manufacturing supplies and order needed items.
- Performs review and signs approval on all maintenance/equipment logs
- Assists in identifying/completing scheduled and unscheduled maintenance on production equipment in conjunction with the Maintenance Department.
- Performs Safety Audits and related activities with the Safety Department per OSHA regulations.
- Assist the Manufacturing Supervisor with prioritization of manufacturing activities and guiding manufacturing Technicians.
- Ensures documentation of processing, log sheets, and training records is complete and accurate.
- Writes Non-Conformance Reports and Corrective and Preventive Action plans as needed.
The above description outlines the most common job duties; however, it does not exclude other potential work assignments
Education or Formal Training Required:
- Associate’s or Bachelor’s degree in Physical or Life Sciences is preferred.
- 2+ years of relevant experience in a regulated (cGMP or ISO) Manufacturing environment, preferably in the Medical Device Industry.
- Working knowledge of all technical steps of manufacturing.
Qualifications Required: (knowledge, skills, abilities, initiative, judgment, etc.)
- Speak, read, and write in English
- Able to communicate moderately complex ideas or issues
- Operate a personal computer and associated software
- Perform simple to moderate mathematical calculations
- Follow specific directions for technical operations
- Moderate mechanical understanding of manufacturing equipment operation and maintenance
- Participates in priority setting
- Has judgment to seek assistance in non-routine situations
- Clean Room experience preferred
- Detail oriented
Work Conditions / Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully preform the essential functions of the job. Reasonable accommodations may be made when requested by the employee to enable individuals with disabilities to perform the essential functions.
- This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely.
- Varies depending upon specific area of responsibility. Primarily production plant, warehouse, or clean rooms.
- Can require lifting up to 50 lbs and significant mechanical abilities.
- Standing for long periods of time.
- Environmental conditions can expose an individual to dust, noise, and odors.
Travel Requirement: Minimal
Benefits/Compensation (including but not limited to)
MMedical and dental insurance, group life insurance, 401k matching, long term disability, potential target bonus, paid time off.
Salary Range: $34.42/hour plus and additional $2.25 for weekend shift differential for a lead role. Total of $36.67/hr.
We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.