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

Intern, Quality Assurance is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging, under close supervision, reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release. Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues. Communicates to multiple departments and supervision to provide timely process and issue updates. Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement.

Job Description

Key Accountabilities

Quality Product Release

Performs physical inspection of in-process and finished product samples as assigned and according to the production scheduleCollects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirementsBecomes competent in at least one process: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, PackagingFollows internal processes related to controlled substancesPerforms GMP related verifications such as line clearances, cleaning, room inspection, and materialsCollects and appropriately labels packaging retain samples, and submits to the archive storageMay execute computer data entries in CME, JDE, LIMS, and/or department databasesMaintains collection of hold time study samples for QC analysisCollects and retains samples and performs sample evaluation for APRMay backup third party product review/releaseReviews, under close supervision, all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product releaseIdentifies errors that have potential product impact, escalates to supervision, and takes action to place lots on Quality Hold as neededConfirms that all Quality events (Change Controls, CAPAs, investigations and any other documentation related to the lot to be released) are complete and closed prior to product releasePrioritizes reviews based on production and shipment schedulesWith guidance, reviews laboratory Certificates of Analysis for accuracy, communicates with the laboratory on COA discrepanciesPerforms MAPICS transactions to release productCollaborates with Quality and Manufacturing personnel to correct errors and address Non-Conformances in a timely mannerCoordinates with production/ warehouse personnel to place material on Quality Hold as needed

Compliance

Follows internal processes related to controlled substancesFollows procedures to ensure compliance to regulatory requirements

Non-Conforming Events

Responds to and escalates events identified during production to Quality ManagementParticipates in investigations with the Rapid Response Team as neededPerforms manufacturing and packaging room inspections and releaseProvide quality direction to operations to resolve floor issues, implement corrections, and assure deviations are openedCollaborates with Manufacturing and Quality partners to identify and implement improvements

Safety

Follows all procedures to ensure a safe and compliant work environment

Qualifications

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 or mechanical engineering

Experience

Required – not applicableDesired – Previous Internship/Co-Op experience.Maintain a professional practice.

Knowledge

Basic knowledge and ability to read and interpret SOPs and function within the scope of procedural requirementsProficient with Microsoft software (e.g. Word, Excel, Project, PowerPoint, Outlook, Visio)

Skills & Abilities

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 succeedAnalytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and proceduresOral 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

Physical Requirements

Lift 15 lbs.Walk across plant/warehouseWear appropriate gowning/PPE as requiredAbility to read for extended periods of time

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.