Supervisor, Operations (Inspection/Packaging)

Manufacturing & Packaging Rochester, Michigan


Description

Description: cid:A1548F0C-58F6-4866-A7F9-03CA2587CEB3

Job Description

 

Job Summary - a concise overview of the job

Responsible for daily coordination, oversight, and execution of working schedules of people and equipment.  Oversees an operational area utilizing hourly union operators that 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, company procedures, and the union contract.  Knowledgeable in cGMPs and good aseptic practices; skillful at communicating, overseeing, and guiding colleagues performance. Responsible for schedule adherence. Responsibility requires documentation, investigative writing, production planning and labor utilization skills. Modifies departmental SOPs, investigates excursions, and executes action items; supporting business and quality objectives. Establishes & 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.

Supervisor of Operations at Rochester, MI manufacturing plant supervises 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

Accountability

Responsibilities

% of Time

Operations

  • Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures.
  • Runs operation to meet or exceed delivery performance objectives.
  • Responsible for schedule adherence.
  • Responsive to changes in daily workflow and schedule; determines needs, redeploys resources, schedules overtime  to achieve delivery & customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation, sanitation, and/or requalification.
  • 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.
  • Performs control checking & reviews GMP(batch records & forms) records prior to submission to Quality; performs yield (ERP) transactions
  • Supports Process Development projects ensuring operator process review, documentation development, and cross-shift communication.
  • Coordinates sampling requirements with QC resources.
  • Interfaces with suppliers of equipment or products and area consultants/experts

20%

Compliance

  • Understands & adheres to good documentation practices (GDP)
  • Initiates & executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure in support of continuous improvement initiatives.
  • Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control.
  • Conducts investigations for cause, determines corrective action, and impact; writes reports & assures timely closure.
  • Initiates & approves maximo work orders for equipment and facility repairs/modifications
  • Reviews operator training programs prior to daily work assignments.
  • Conducts or assists training for batch records, SOP's, and cGMP's, and maintains documentation.
  • Maintains a safe work environment. Complies with company Safety policies and OSHA Regulations. Participates in development & maintenance of a safe manufacturing environment.  Establishes methods in compliance with regulatory, plant, and corporate policies.  Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions.
  • Develops cleaning & sanitation procedures using qualified agents. Keeps current with industry practices/requirements for environmentally graded operating areas.

25%

Leadership

  • Drives operational performance. Troubleshoots or resolves issues impeding department objectives/deliverables; proactively demonstrates the ownership to achieve.
  • Consistently communicates. Reports production updates at daily meetings. Keeps manager/director informed of operations; elevates as needed.
  • Counsels, trains, & develops operators for efficient performance; creates an atmosphere of team effort & open communication.
  • Assures operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback.
  • Resolves conflict including disciplinary actions; complies with union contract.
  • Directs manpower. Monitor performance and attendance of all personnel. Makes personnel utilization decisions and PTO requests based on total queue, backlog, and resource capacity.

30%

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

Education

  • Required- B.A. /B.S. Degree in Science, Business or related field or required experience.
  • Desired- B.A. /B.S. Degree in Science and/or Management degree

Experience

  • Required – 2 years minimum as an operator or quality specialist/technician with increasing levels of proficiency or equivalent.
  • Desired – 2 years minimum as an operator or quality specialist/technician within a Pharmaceutical Operation.

Knowledge

Proficiency in a body of information required for the job 

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Experience in aseptic processing or pharmaceutical operations preferred.
  • Knowledge of MS Office Suite and general computer-based applications
  • Understanding of current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA
  • Personnel from outside the pharmaceutical industry or a directly related industry, i.e., medical devices, food, etc., can be considered after critical assessment of their industry related knowledge.

Skills

&

Abilities

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 DrivenLeadership Teamwork Innovation and Continuous Improvement

 

Endo Job Description Template - Revised July 2014