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
+ Performs control checking & reviews GMP(batch records & forms) records prior to submission to Quality; performs yield (ERP) transactions
+ Supports oversight of hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures.
+ Assures the cleanliness of the operating areas; responsible for assuring that operating areas meet CFR and environmental graded classifications (i.e. ISO, EMA classifications) per standard operating procedures.
+ Ensure all equipment is working properly.
+ Supports Process Development projects ensuring operator process review, documentation development, and cross-shift communication.
+ Coordinates sampling requirements with QC resources.
+ Understands & adheres to good documentation practices (GDP)
+ Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control.
+ Initiates maximo work orders for equipment and facility repairs/modifications
+ Conducts or assists training for batch records, SOP's, and cGMP's, and maintains documentation.
+ Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions.
+ Troubleshoots or resolves issues impeding department objectives/deliverable.
+ Consistently communicates. Keeps manager/director informed of operations; elevates as needed.
+ Participates in creating an atmosphere of team effort & open communication.
+ Assures operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback.
+ Monitor performance of personnel.
+ Develops skills upwards and including those expected from a Supervisor, Operations through increased time as a Co-Op Supervisor.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
+ Required- High School Diploma, and enrolled in a program for a B.A. /B.S. Degree in Science, Engineering, Business or related field or required experience.
+ Desired – B.A. or B.S. program with interest in Manufacturing envionments
+ Required – not applicable
+ Desired – Previous Co-Op experience.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
+ Knowledge of MS Office Suite and general computer-based application
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:
+ Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
+ Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
+ Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
+ Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
+ Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
+ Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
+ Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
+ Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs and intended audience; Presents numerical data effectively; Able to read and interpret written information.
+ Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed
+ Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures
To perform the job successfully AND progressively achieve, an individual should demonstrate the following competencies:
+ Design -Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
+ Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
+ Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility/accountability for own actions; Follows through on commitments.
+ Initiative -Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
+ Resilience - Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set backs.
+ Problem Solving -Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
+ Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
+ Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
+ Adaptability -Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
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.
+ Routine entry into a manufacturing environment that requires garbing in and out of controlled areas; may include environmentally controlled areas up to ISO Grade 5.
+ Stand, Walk, Sit, Talk and/or Hear
+ Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.
+ Specific vision abilities required by this job include close vision
+ Frequently working near or exposed to moving mechanical parts
+ The noise level is moderate
+ Occasional exposure to fumes, airborne particles, toxic or caustic chemicals
+ Work environment is a production/manufacturing plant
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