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
Performs data collection for operational performance metrics and improvement initiatives. Drives operational efficiency using collected data. Obtains knowledge in cGMPs and good aseptic practices. Develops skills upwards and may include aspects of Supervision over time. Developed duties may include control checking & review of GMP records (batch records & forms); performing yield (ERP) transactions. Develops and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Process Development, and Supply Chain to meet plant objectives. Gradually increasing exposure to oversight of people and equipment.
Exposure to people oversight may include that of hourly union operators that may dispense materials, formulate, clean and sterilize equipment and components, conduct primary filling, lyophilization and/or terminal sterilization, inspection, labeling, and/or packaging of a variety of products, including Par branded, development & generic as well as contract customer products while meeting department quality, safety, delivery and productivity 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.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Job Description
Scope of Authority
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Co-Op, Operations 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.
Key Accountabilities
Operations
- 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.
Compliance
- Understands & adheres to good documentation practices (GDP)
- Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control.
Leadership
- 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.
Qualifications
Education & Experience:
- Must be currently enrolled in an undergraduate or graduate program, in a relevant field of study to the internship you are applying for (Chemistry, Biology, or Engineering)
Knowledge
- Knowledge of MS suite of products
- Strong written and oral communication skills.
- Proficient in PC programs, including Microsoft Office.
Skills & Abilities
- Requires a student with strong communication skills, the ability to think strategically, and demonstrate leadership potential.
Physical & Work Requirements
- 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
Disclaimer: 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.
