What are the responsibilities and job description for the Intern, Operations Support position at Endo?
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 Intern, Operations Support, 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.
Intern, Operations Support at Rochester, MI manufacturing supports indirect supervision of personnel across a shift. Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice.
Equipment dependent on area focus, may include: formulation vessels (sterile and non-sterile), lab equipment (pH, DO, Temperature), scales, and automatic filter integrity testers, sterilizers, Isolators, Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, and Terminal Sterilizers, Sterilizers, Sanitation equipment, Inspection equipment (manual, semi-automated, automated), labelers, vision systems, cartoners, serialization systems.
Accountability & Responsibilities
Operations - 40%
Education
To perform the job successfully, an individual should demonstrate the following competencies:
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.
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 Intern, Operations Support, 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.
Intern, Operations Support at Rochester, MI manufacturing supports indirect supervision of personnel across a shift. Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice.
Equipment dependent on area focus, may include: formulation vessels (sterile and non-sterile), lab equipment (pH, DO, Temperature), scales, and automatic filter integrity testers, sterilizers, Isolators, Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, and Terminal Sterilizers, Sterilizers, Sanitation equipment, Inspection equipment (manual, semi-automated, automated), labelers, vision systems, cartoners, serialization systems.
Accountability & Responsibilities
Operations - 40%
- Performs data collection for operational performance metrics and improvement initiatives. Drives operational efficiency using collected data.
- Performs control checking & reviews GMP(batch records & forms) records; performs yield (ERP) transactions
- Indirect oversight of hourly operators in execution of daily work.
- Supports Process Development projects ensuring operator process review, documentation development, and cross-shift communication.
- Coordinates sampling requirements with QC resources.
- Develops and conducts effective training programs
- Recommends tools/methods to monitor and improve the efficiency of processes
- Provides advanced analysis of work process activities and associated process data to effectively improve efficiency
- Performs root cause analysis and corrective action methodologies
- Supports the ongoing resolution of deviations
- Supports Risk Management programs and initiatives
- Ensures best practices, processes, and procedures are defined, documented, and implemented company-wide that satisfy quality systems requirements
- Understands & adheres to good documentation practices (GDP)
- Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control.
- Consistently communicates; elevates as needed.
- Participates in creating an atmosphere of team effort & open communication.
- Monitor performance of personnel.
- Develops skills upwards and may include those from a Supervisor.
Education
- Required- High School Diploma, and enrolled in a program for a B.A. /B.S. Degree in Science, Engineering, Business or related field or required experience. Proof of academic enrollment must accompany application.
- Desired – B.A. or B.S. program with interest in Manufacturing environments; preferably industrial engineering
- Required – not applicable
- Desired – Previous Internship/Co-Op experience.
- Maintain a professional practice.
- Knowledge of MS Office Suite and general computer-based application
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
- 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.
- 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.
- 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 controlled areas; may include 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.
