Operations Support Specialist, Production Administration, 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 Operations Support Specialist, with support of Site Leadership, sponsors a quality and compliance focused culture embracing RFT (right the first time) and CI (continuous improvement) expectations. Position is a key conduit of information and the first line of integrating Quality into the manufacturing processes. Knowledge is required in multiple operational areas: Dispensing, compounding, filling, inspection, and packaging operations. The Operations Support Specialist is a subject matter expert in at least one area of operations. Experience in Quality Management Systems is required; conducting investigations, troubleshooting events, and implementing effective CAPA required.
+ Liaises between departments to drive timely resolution with an expected outcome that cycle times and batch process times would be reduced and be right first time.
ROLE AND RESPONSIBILITIES:
+ Develops training materials along with proficiency demonstration tools for qualifying operators and supervisory team. Assures these materials are integrated into the Learning Management System (LMS); standardizing training and ensuring knowledge transfer.
+ Subject matter expert (SME) in one area of operations; works in cooperation with cross-function group leads. Ensures programs are compliant and continuously improving. Areas of specialty include, but not limited to: Aseptic Processing, Inspection Program, Cleaning/Sanitation programs, Good Documentation Practices.
+ SME for program presentations during audits/inspections; ensures operational oversight of programs exist.
+ Observes process execution and collects data. Applies basic statistical concepts and communicates findings to down-stream OR up-stream operators and management.
+ Collects surveillance or protocol driven data; focus is on process analytical technology data that captures opportunities (waste monitoring) that can result in predictive and preventative action as well as process improvement.
+ Evaluates process data such as rejects & reject rates; makes on-time decisions to adjust processes & document accordingly. Communicates findings to down-stream OR up-stream processing departments
+ Provides shop floor oversight to identify production operation improvements in training, processes or equipment
+ Conducts and documents periodic on-line inspections to ensure production/validation activities are conducted in accordance with SOPs and quality requirements
+ Leads and/or participates in investigations; writes reports/protocols; emphasis on resolution, prevention and/or solutions to technical problems, decreasing cycle times for quality management system deviation and CAPA closures.
+ Leads operational changes and project, thru change control
+ Frequent communication with operators, operations management, quality, and cross-functional support groups required
+ Indirect supervisory responsibilities for operational personnel; contributes to personnel review, feedback, training and development of staff.
+ Required- B.A. /B.S. Degree in Science or related field or greater than 3 years’ experience.
+ Minimum 3 years in Pharmaceutical Operation or Quality Department with increasing levels of responsibility/experience.
+ Minimum 2 years writing/executing investigations and change controls.
+ Minimum 2 years aseptic processing knowledge.
+ Knowledge and understanding of manufacturing processes, facilities and processing equipment, as well as cGMPs, SOPs and regulatory requirements. Robust knowledge & expertise in aseptic processing preferred.
+ Strong computer/systems skills using Quality Management Systems, MS Office Suite, and/or Enterprise Resource tools (i.e., Trackwise, JD Edwards/SAP, ComplainceWire, Maximo, MasterControl or similar).
+ Strong technical writing and presentation skills.
Skills & Abilities
+ Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures
+ 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.
+ 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.
+ 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.
+ Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
+ 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.
+ Design -Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
+ 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.
+ 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.
To perform the job successfully and progressively achieve, an individual should demonstrate the following competencies:
+ 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.
+ Resilience - Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set backs.
+ Project Management – Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities
+ Change Management – Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
+ Quality Management – Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness
+ 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
+ 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.
+ 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.
+ 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
+ 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