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.

　　Performs Quality laboratory microbiological analyses of materials including water testing, finished product testing, raw material testing, and method validation. Supports laboratory investigations of moderate scope and complexity while abiding by GMPs and GLPs. Has working knowledge of, and stays current with, regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing.

　　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.

　　Typically supports one Par business, at a single site

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

　　Accountability

　　Responsibilities

　　% of Time

　　Microbiology Lab

　　Conducts microbiological analyses: water testing, finished product testing, raw material testing, environmental monitoring, media preparation, method verification and validation, and identification of microorganisms

　　Performs day-to-day operations of the Microbiology Lab to ensure that cGMPs, GLP’s and all other applicable compendia requirements are met

　　Schedules monitoring and samples for testing/inspection, reviews data and ensures monitoring, testing, and inspection is completed per approved procedures

　　Reviews test data and ensures testing is performed based on approved procedures

　　May review testing/inspection results and disposition incoming/in process/finished product

　　May perform pour plates techniques, membrane filtration, and pure culture isolation

　　Records results from tests, interprets colony morphology, and accurately maintains laboratory data

　　Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends corrective actions

　　65%

　　SOPs

　　Validates/qualifies test procedures and equipment used for various testing/inspection activities performed by Quality

　　Reviews and updates SOPs and procedures for Quality as needed

　　Reviews and comments on the articles affecting Quality in the USP Supplements and Pharmacopeial Forums

　　Oversees maintenance, logbooks, and expiration dates of stock cultures, media, and sterilization documents

　　15%

　　Compliance & Investigations

　　May perform gap assessments for procedures for the various Quality programs (EM, incoming/in process/ finished product Inspection, component/raw material/product review and disposition) to ensure cGMP compliance

　　Supports laboratory investigations of moderate scope and complexity while abiding by GMPs and GLPs

　　Assists in performing microbiological audits of facilities

　　Follows internal processes related to controlled substances

　　10%

　　Lab Equipment

　　Maintains laboratory equipment in clean order; reports equipment problems to Supervisor

　　Performs laboratory equipment qualifications

　　Learns to troubleshoot basic instrument problems

　　5%

　　Training

　　Demonstrates responsibility in training others in good documentation practice, practical lab skills, and microbiological theories, methodologies and procedures

　　Maintains assigned training records current and in-compliance

　　5%

　　Safety

　　Follows EH&S procedures to ensure a safe work environment

　　Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS

　　Continuous

　　Total

　　100%

　　Qualifications

　　Education & Experience

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

　　Bachelor of Science degree in microbiology, biology or related field with 2+ years’ relevant microbiology laboratory experience OR

　　Master of Science degree in above disciplines with 1+ year’ relevant pharmaceutical lab experience 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.

　　Demonstrated proficiency with microbiology techniques and instruments

　　Demonstrated competence in conducting microbiological analyses

　　Knowledge of regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing

　　Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS

　　Competency in Microsoft Office Suite

　　Knowledgeable in aseptic techniques

　　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 display and analyze data in a logical manner

　　Good verbal and written communication skills as well as good computer skills

　　Attention to details and accurate record keeping

　　Ability to establish and maintain cooperative working relationships with others

　　Solid organizational skills

　　Ability to take initiative, set priorities and follow through on assignments

　　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.

　　Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals

　　Must occasionally lift and/or move up to 15-25 lbs.

　　Ability to wear personal protective equipment, including respirators, gloves, etc..

　　Specific visions abilities are required by this job include close vision and color vision.

　　Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

　　The work environment is representative of a group laboratory environment.

　　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.

　　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.

　　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.