Co-Op Supervisor, Operations (Days)
Co-Op Supervisor, Operations
Direct Reports (list)
Reports to (title)
Supervisor, Operations or above
To be completed by Corporate Compensation:
FLSA (USA only)
Job Summary - a concise overview of the job
Performs control checking & reviews GMP(batch records & forms) records prior to submission to Quality; performs yield (ERP) transactions. Supports daily oversight of people and equipment. Hourly union operators may dispense materials, formulate, clean and sterilize equipment and components, conduct primary filling, lyophilization and/or terminal sterilization, inspection, labeling, and/or packaging of a variety of products, including Par branded, development & generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives. Ensures people and processes comply with Good Manufacturing Practices and company procedures. Obtains knowledge in cGMPs and good aseptic practices. Responsibility requires documentation, investigative writing, production planning and labor utilization skills. Modifies departmental SOPs and executes action items; supporting business and quality objectives. Develops skills upwards and including those expected from a Supervisor, Operations through increased time as a Co-Op Supervisor. Develops and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Process Development, and Supply Chain to meet plant objectives.
In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Co-Op Supervisor of Operations at Rochester, MI manufacturing supports supervision of 15-20 personnel across a shift. Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice.
Equipment dependent on area focus, may include: formulation vessels (sterile and non-sterile), lab equipment (pH, DO, Temperature), scales, and automatic filter integrity testers, sterilizers, Isolators, Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, and Terminal Sterilizers, Sterilizers, Sanitation equipment, Inspection equipment (manual, semi-automated, automated), labelers, vision systems, cartoners, serialization systems.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
To perform the job successfully, an individual should demonstrate the following competencies:
For internal candidates: meets or exceeds expectations as follows:
To perform the job successfully AND progressively achieve, an individual should demonstrate the following competencies:
Physical & Work Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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Customer Focus – Results Driven – Leadership – Teamwork – Innovation and Continuous Improvement
Endo Job Description Template - Revised July 2014