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.

　　The Quality Associate Specialist, Product Release, 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. In addition, confirms that all related Quality events such as CAPAs, Change Controls, etc. are closed prior to releasing the product. Partners with other departments to ensure that errors are addressed and corrected. Identifies errors that have potential product impact, escalates to supervision, and takes action to place lots on Quality Hold as needed. Ensures release meets internal requirements and is performed in a timely and accurate manner.

　　Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

　　Supports one component of the Generics business, mainly within a single site.

　　Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

　　Accountability

　　Responsibilities

　　% of Time

　　Quality Product Release

　　Reviews, 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 release

　　Identifies errors that have potential product impact, escalates to supervision, and takes action to place lots on Quality Hold as needed

　　Confirms 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 release

　　Prioritizes reviews based on production and shipment schedules

　　With guidance, reviews laboratory Certificates of Analysis for accuracy, communicates with the laboratory on COA discrepancies

　　Performs MAPICS transactions to release product

　　Collaborates with Quality and Manufacturing personnel to correct errors and address Non-Conformances in a timely manner

　　Coordinates with production/ warehouse personnel to place material on Quality Hold as needed

　　100%

　　Compliance

　　Follows internal processes related to controlled substances

　　Follows procedures to ensure compliance to regulatory requirements

　　Continuous

　　Safety

　　Follows all procedures to ensure a safe and compliant work environmentContinuous

　　Total

　　100%

　　Qualifications

　　Education & Experience

　　Minimal acceptable level of education, work experience and certifications required for the job

　　BA/BS degree in a related discipline with 0-1 year of relevant experience

　　Experience in Quality Operations preferred

　　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.

　　Basic knowledge and ability to read and interpret SOPs and function within the scope of procedural requirements

　　Knowledge and ability to work with and navigate computer systems such as MAPICs and LIMS

　　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.

　　Ability to handle and integrate multiple pieces of data to assure correctness

　　Ability to work with cross-functional teams

　　Able to recognize and identify complex errors such as calculation conversions

　　Able to reconcile batch record entries with other documentation

　　Proof-reading skills and ability to identify errors

　　Customer/stakeholder focused, understands impact of daily work to compliance and business

　　Communication skills

　　Strong basic math skills

　　Ability to follow complex processes

　　Attention to detail

　　Strong documentation skills

　　Physical Requirements

　　Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

　　Lift 15 lbs.

　　Walk across plant/warehouse

　　Wear appropriate gowning/PPE as required

　　Ability 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.

　　Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.

　　All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.