Malone
Job ID: 317778
Salary $60k – $75k
Supervise the activities of the chemical production operators in a cGMP manufacturing environment, conduct employee training, manage production to schedule, and participate in production (as needed). Troubleshoot / correct manufacturing process related issues in collaboration with other departments as required. Responsible for employee safety, and ensuring compliance with all procedures and regulatory requirements.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
- Supervise the activities of chemical production operators in a cGMP manufacturing environment.
- May supervise the activities of other departments as required (maintenance, shipping).
- Plan, schedule, and coordinate departmental activities (including staffing) to fulfill sales orders, meet inventory requirements, and deliver manufactured products in accordance with established procedures and approved processes.
- Responsible for site security, safety and proper shutdown at conclusion of shift, as appropriate. Conduct shift handovers with 1st & 2nd shift supervisors.
- Supervise and participate in the production operations (as necessary).
- Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data.
- Ensures proper manufacturing processes are followed in accordance to written documentation (i.e., Batch Records, cGMPs, SOP’s, Work Instructions).
- Maintains and revises procedures associated with production processes to ensure accuracy, consistency and product quality, in collaboration with Quality Assurance.
- Create, edit, and maintain necessary documentation (SOP’s, Work Instructions, On-the-Job Training).
- Ensure all manufacturing safety policies and procedures are implemented and maintained at all times. Ensure appropriate PPE is worn by operators during production operations.
- Investigates and eliminates departmental non-conformities in manufacturing processes by employing root cause analysis and implements corrective and preventative actions.
- Analyze and design lean manufacturing cells using effective systems to optimize use of space, equipment, material, personnel and increase capacities.
- Assist in developing plant layout in planning rearrangement of facilities, equipment and operations for better utilization of space and to increase capacities.
- Supports process validations by defining process to quality parameters, executing protocols, collecting/interpreting data and supporting protocol summary where needed.
- Monitors work for accuracy, neatness, and conformance to policies and procedures.
- Trains, motivates, monitors and evaluates performance of manufacturing employees.
- Develop and implement departmental cross training initiatives to allow for flexible resources and aid in improved capacities.
- Actively participates with internal and/or customer audits as needed.
- Works closely with internal departments (including QC, QA, EH&S, maintenance) to assure commitment to customer is met in a timely manner.
- Performs other duties as assigned.
QUALIFICATIONS (Education/Training, Experience and Certifications)
- Bachelor’s degree in a technical field, preferably life science, chemistry and/or engineering discipline, or equivalent experience required.
- Minimum 5 years of progressive manufacturing experience and responsibilities, 1 of which must be in a supervisory capacity; or equivalent combination of education and experience.
- Life science, chemistry, chemical engineering or chemical production experience required.
- Experience in cGMP manufacturing preferred.
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
- Familiarity with chemical and/or aseptic production processes and applications within similar industry preferred.
- Highly organized and self-motivated individual who can work independently with little supervision.
- Must have strong leadership skills and problem solving abilities.
- Excellent oral and written communication skills.
- Ability to perform risk assessment of products and processes and develop corrective measures.
- Must be able to manage multiple tasks and priorities and easily adapt to changing situations.
- Computer literacy applied to scheduling, procedure revisions and data/inventory management is required.
- Ability to take initiative, meet deadlines, and lead people in a team environment essential.
- Proven track record of reducing costs through process improvements and efficiencies.
- Must be hands-on, team oriented, and committed to business improvement processes.
- Lean manufacturing experience a plus.
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