Sr Supervisor, Bulk Manufacturing (Day Shift)

Manufacturing & Packaging Rochester, Michigan


Description

Supervisor, Bulk Manufacturing, Operations and Manufacturing, Michigan-Rochester

 

About Endo International plc

Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA, employing approximately 3,000 people worldwide.  For 2018 Endo, reported revenue of $2.947B and adjusted diluted EPS of $2.89.  Learn more at www.endo.com.

 

POSITION SUMMARY:

Responsible for operations utilizing union personnel on day shift for compounding of product and sampling/dispensing activities.  Operations produce a variety of drug and biological products including Par branded, development and generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives.    Ensures the facilities, equipment, supervision, and staff are properly trained to produce aseptically filled pharmaceutical products.  Ensures coordination of activities with all supporting departments. Establishes objectives for the department and metrics reporting.  Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract.  Responsible for oversight union personnel in Bulk Manufacturing and Drug & Chemical (D&C).  Initiates and/or reviews/approves department standard operating procedures, investigations, and change controls to support 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.

Supervisor overseeing Bulk and D&C operations at Rochester, MI manufacturing plant; responsible for 10 union personnel.

 

ROLE AND RESPONSIBILITIES:

Operations

  • Runs operation to meet or exceed delivery performance objectives for product or projects.
  • Responsive to changes in daily workflow and schedule; determines needs  & redeploys resources and/or overtime  to achieve delivery & customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation.
  • Ensure all equipment is working properly.
  • Maintains a safe work environment.

 

Compliance

  • Understands & adheres to good documentation practices (GDP)
  • Drives Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure.
  • Confidently demonstrates knowledge and executes proficiently in at least one QMS area: deviation management and/or change control.
  • Conducts investigations for root cause, determines corrective action, and impact; writes reports & ensures timely closure.  Approves investigations and/or change control plans.
  • Counsels, trains, & develops union colleagues for efficient performance; creates an atmosphere of team effort & open communication.
  • Initiates & executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes.
  • Approves Maximo work orders
  • Creates, reviews, approves, and conducts operator training programs & assures operator training is conducted on SOPs, cGMP, and safety.
  • Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance.
  • Follow and comply 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.

 

Supervisory

  • Reports daily production updates at daily Huddle or SMART meetings.
  • Ensures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations.
  • Direct manpower as needed, resolve conflict and assume all aspects of leadership including oversight of disciplinary actions.
  • Monitor performance and attendance of all off-shift personnel
  • Makes personnel utilization and PTO requests decisions based on production demand and resource capacity.
  • Assigns projects for continuous improvement.
  • Requests equipment and facility repairs, or modifications.
  • Understands & complies with Union Agreement.

 

Leadership

  • Develops & reports departmental metrics.
  • Participates in recruitment, selection, promotion, & retention of personnel.
  • Reviews operational performance; drives improvement opportunities.
  • Recognize and reward employees that consistently perform at high levels or go above and beyond their required job duties in order to maintain a high level of employee morale.
  • Consistently communicate, follow and enforce SOP’s, company policies,  guidelines set forth in the employee handbook.
  • Identify developmental needs of others; provide coaching, mentoring, and encouragement to help others to improve their knowledge or skills.
  • Provide regular coaching and performance feedback to employees in addition to conducting annual performance reviews.  Recognize and implement performance improvement plans when needed in consultation with Human Resources Business Partner.
  • Troubleshoots or resolves issues impeding department objectives/deliverables; proactively demonstrates the ownership to achieve.
  • Interfaces with suppliers of equipment or products and area consultants/experts
  • Conducts/supports CMO audits or regulatory agency inspections.

 

REQUIRED QUALIFICATIONS:

Education & Experience

Education

  • Required- B.A. /B.S. Degree in Science, Business or related field or significant experience.
  • Desired- B.A. /B.S. Degree in Chemistry, Microbiology, and/or Engineering

Experience

  • Desired – 2 years as an Operation Supervisor or equivalent experience

 

Knowledge

  • Knowledge of Enterprise Resource Planning tools (JD Edwards); Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite; ADP, Maximo, etc.
  • Solid understanding of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA

 

Skills & Abilities

To perform the job successfully, an individual should demonstrate the following competencies:

For internal candidates: meets or exceeds expectations for competencies outlined in the Supervisor and Sr. Supervisor Operational Area (Sanitation, Bulk, Prep Services, Sterile Filling) Job Descriptions in addition to the following:

  • Project ManagementDevelops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities
  • Change ManagementDevelops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
  • Managing PeopleIncludes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self-available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills
  • Quality ManagementLooks for ways to improve and promote quality; Demonstrates accuracy and thoroughness
  • Cost ConsciousnessWorks within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources
  • JudgementDisplays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions
  • Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention

 

To perform the job successfully AND progressively achieve, an individual should demonstrate the following competencies:

  • Customer ServiceManages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments
  • Visionary LeadershipDisplays passion and optimism; Inspires respect and trust; mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates
  • DelegationDelegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results
  • LeadershipExhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others
  • Business acumen- Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals
  • Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce
  • Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values
  • Organizational supportFollows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity
  • Strategic ThinkingDevelops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions

 

PHYSICAL REQUIREMENTS:

  • Routine entry into a manufacturing environment that requires garbing in and out of 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

 

ADDITIONAL INFORMATION:

  • Afternoon shift premium is 10% (non-union positions only)
  • Midnight shift premium is 15% (non-union positions only)

 

 

Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.

 

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

 

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