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 Summary
The Workforce Development Specialist, with support of Site Leadership, sponsors a quality and compliance focused culture embracing RFT (right the first time) and CI (continuous improvement) expectations. This 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 Workforce Development 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.
Responsibilities
% of Time
Compliance
- 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.
50%
Operations
- 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
30%
Quality
- 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
20%
Leadership
- 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.
Continuous
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 or related field or greater than 3 years’ experience.
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
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- 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
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.
- 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.
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
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.
