Technical Supervisor, Sterile Filling; Suite-C
Technical Supervisor, Sterile Filling, Compression & Cap, 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.
The Supervisor, Sterile Filling is responsible for daily coordination and execution of working schedules of people and equipment in Sterile Filling. Responsible for supervising hourly union operators that conduct primary filling, lyophilization and/or terminal sterilization of a variety of drug and biological products, including Par branded, development & generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives. Responsible for direct supervision of one or more aseptic filling lines. Typically this will involve 3 to 6 operators per line. Supervisors are highly knowledgeable in cGMPs and good aseptic practices; must be skillful at communicating, teaching, and inspiring colleagues to a high level of performance. Responsibility requires a high level of documentation, investigative writing, production planning and labor utilization skills. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Initiates, and/or reviews department standard operating procedures to support business and quality objectives. Establishes 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.
Supervisor of Sterile Filling operations at Rochester, MI manufacturing plant; personnel across one shift.
Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice.
Significant Equipment includes: Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, and Terminal Sterilizers
ROLE AND RESPONSIBILITIES:
- Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures
- Develops daily/weekly department work schedules, set priorities and verifies availability of resources
- Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilization
- Responsive to changes in daily workflow and schedule; determines needs and redeploys resources and/or overtime to achieve delivery and 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
- Reviews batch records and supporting records prior to submission to Quality
- Maintains a safe work environment
- Completes in-process, set up checks and verification in alignment with Standard Operating Procedures
- Understands and adheres to good documentation practices (GDP)
- Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure
- 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 and assures timely closure
- Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes
- Initiates and approves maximo work orders for equipment repairs or modifications
- Creates, reviews and conducts operator training programs and 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
- Reports production updates and schedule changes to team and/or at daily Huddle or SMART meetings
- Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback
- Assigns manpower; initiates documentation of violations and disciplinary action with operators as required
- Requests equipment and facility repairs, or modifications
- Understands and complies with Union Agreement
- Keeps manager informed of operations; elevates as needed
- Reviews operational performance; drives improvement opportunities
- Counsels, trains, and develops union colleagues for efficient performance; creates an atmosphere of team effort & open communication
- Consistently communicate, follow and enforce SOP’s and company policies and guidelines set forth in the employee handbook
- Troubleshoots or resolves issues impeding department daily/weekly 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- B.A. /B.S. Degree in Science, Business or related field or significant experience
- Desired- B.A. /B.S. Degree in Packaging, Science and/or Management degree
- Required – None
- Desired – 1-3 years in Pharmaceutical Packaging, Operation or Quality Department with increasing levels of responsibility or equivalent
- Knowledge of Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite; Kronos, Maximo
- Solid understanding of all 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. Must be able to gain knowledge and expertise in aseptic processing
Skills & Abilities
To perform the job successfully, an individual should demonstrate the following competencies:
- 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.
- 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
- 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