Supv, Sterile Filling

Why Endo?We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.Job Description SummaryThe 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.Job DescriptionScope 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 Sterile Filling operations at Rochester, MI manufacturing plant; personnel across one shiftSecurity-sensitive (highly sensitive) position under the Controlled Substance Abuse PracticeSignificant Equipment includes: Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, and Terminal SterilizersKey Accountabilities - key outcomes/deliverables, the major responsibilities, and % of timeAccountabilityResponsibilities% of TimeOperationsOversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating proceduresDevelops daily/weekly department work schedules, set priorities and verifies availability of resourcesResponsible 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 investigationEnsure all equipment is working properlyReviews batch records and supporting records prior to submission to QualityMaintains a safe work environmentCompletes in-process, set up checks and verification in alignment with Standard Operating Procedures20%ComplianceUnderstands and adheres to good documentation practices (GDP)Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closureObtains knowledge and executes assignments in QMS areas: deviation management and/or change controlConducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closureInitiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processesInitiates and approves maximo work orders for equipment repairs or modificationsCreates, reviews and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safetyAssure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure complianceFollow and comply with company Safety policies and OSHA RegulationsParticipates 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 conditions25%SupervisoryReports production updates and schedule changes to team and/or at daily Huddle or SMART meetingsAssures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedbackAssigns manpower; initiates documentation of violations and disciplinary action with operators as requiredRequests equipment and facility repairs, or modificationsUnderstands and complies with Union AgreementKeeps manager informed of operations; elevates as needed25%LeadershipReviews operational performance; drives improvement opportunitiesCounsels, trains, and develops union colleagues for efficient performance; creates an atmosphere of team effort & open communicationConsistently communicate, follow and enforce SOP's and company policies and guidelines set forth in the employee handbookTroubleshoots or resolves issues impeding department daily/weekly objectives/deliverables; proactively demonstrates the ownership to achieveInterfaces with suppliers of equipment or products and area consultants/expertsConducts/supports CMO audits or regulatory agency inspections30%Total100%QualificationsEducation & ExperienceMinimal acceptable level of education, work experience and certifications required for the jobEducationRequired- B.A. /B.S. Degree in Science, Business or related field or significant experienceDesired- B.A. /B.S. Degree in Packaging, Science and/or Management degreeExperienceRequired - NoneDesired - 1-3 years in Pharmaceutical Packaging, Operation or Quality Department with increasing levels of responsibility or equivalentKnowledgeProficiency 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 Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite; Kronos, MaximoSolid understanding of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEAPersonnel 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 processingSkillsAbilitiesOften 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 succeedAnalytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and proceduresTo 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 RequirementsPhysical & 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 environmentally controlled areas up to ISO Grade 5.Stand, Walk, Sit, Talk and/or HearOccasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.Specific vision abilities required by this job include close visionFrequently working near or exposed to moving mechanical partsThe noise level is moderateOccasional exposure to fumes, airborne particles, toxic or caustic chemicalsWork environment is a production/manufacturing plantDisclaimer: 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.Commitment to Diversity, Equity, and Inclusion: At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.EEO Statement:At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.