This position will be responsible for the development and performance of the Manufacturing team in a medical/pharmaceutical environment ensuring compliance with cGMP standards, FDA regulations, and company policies. Lead and promote continuous improvement projects to maximize efficiencies in order to exceed customer expectations.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Responsible for the prioritization and manufacturing of products to meet the master production schedule.
2. Responsible for hiring decisions related to manufacturing needs.
3. Responsible to ensure complete and accurate records are maintained for every manufactured assembly (Batch Production Record) to support build plan for multiple locations as necessary.
4. Provide leadership in team building, planning, and establishing clear measures that keep everyone focused on results, the customer, and accomplishing our goals.
5. Create, review, and maintain training records to ensure employees are trained on tasks they perform.
6. Assist employees in resolving their issues and problems. Consult with Human Resources to resolve, if necessary.
7. Work with Manufacturing Engineering group to ensure equipment is qualified and processes released prior to builds.
8. Work with Production Planning, Purchasing, and Logistics to confirm equipment and supplies are available for work orders prior to the start of manufacturing process.
9. Ensure desired inventory levels are maintained for manufactured parts.
10. Monitor labor hours and work with manufacturing personnel to maximize efficiencies in personnel and equipment.
11. Coordinate Engineering Change Orders (ECOs) into the production schedule as required.
12. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
13. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.
Ability and willingness to travel up to _5_% of the time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor’s degree in Business Administration or Operations Management and 5 or more years of experience within a cGMP medical/pharmaceutical manufacturing environment preferred; or equivalent combination of education and experience.
Proficient knowledge of Microsoft Office software programs, including Excel, Word, and Outlook. Experience with MAS ERP a plus.
Supervise the recruitment, training, development, appraisal, and work assignments of direct reports.
• Excellent communication skills, verbal and written
• Strong problem solving skills
• Ability to handle multiple tasks simultaneously
• Ability to work in a fast-paced environment
• Adaptable to change in the work environment
• Ability to work in a team environment, as well as independently
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.