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Endo International QC Analyst II - Chemistry in Horsham, Pennsylvania

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 QC Analyst II - Chemistry will provide bioanalytical expertise for the Quality Control (QC) department. Key areas of focus are development and implementation of the quality aspects of late stage or marketed product strategy. This role is involved with performing and assisting with OOS investigation and resolution. Additionally, the Analyst II will have responsibility for coordinating the bioanalytical technology transfer from outside departments and to outside contractors.

Job Description

Responsibilities

QC

Testing/Safety

  • Testing responsibilitiesmayincludeRP-HPLC,SEC,KF,FT-IR,SDS-PAGE,and UV-Vis.

  • AdherestoCompanysafetyproceduresand guidelines on a dailybasis.

Documentation

  • Completesappropriatedocumentation to supporttesting proceduresincluding datacaptureforms,equipmentlogbooks,and inventoryforms.

GMP Compliance

  • Applies knowledge of Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.

Technical Writing & Investigations

  • Assists with preparing new SOPs / test methods or revising of existing documentation.

  • Performs and assists with OOS investigations, deviation response, and resolution.

  • Writes Change Controls, Deviation Investigations (DI’s), Laboratory Assessments (LA’s), CAPA’s, and OOS investigation.

Technical Transfer

  • Coordinates bioanalytical technology transfer from outside departments and to outside contractors.

Other Tasks

  • Otherdutiesasassigned by QC management.

Education & Experience

  • B.S. in a Biological Science or related field with a minimum of 3-5 years’ experience in pharmaceutical or biotechnology industry required OR

  • M.S. in a Biological Science or related field with a minimum of 1-3 years’ experience in pharmaceutical or biotechnology industry.

  • Generalexperiencein a development,quality, or manufacturing environmentpreferred.

Knowledge

  • Working knowledge in protein chemistry and standard analytical techniques used in the biopharmaceutical industry (e.g., HPLC, FT-IR, SDS-PAGE, UV-Vis, IEF, Capillary Electrophoresis, ELISA).

  • Working knowledge of cGMPpractices,ICH requirements,stability,andvalidationrequired.

  • Understanding of basic statistical analysis and familiarity with the use of databases is desirable.

Skills & Abilities

  • Strong verbaland communication skillsrequired.

  • Proficientincommonsoftwareapplications.

  • Abilitytohandle multipleprioritiesin a fast-paced environment.

  • Demonstratesexcellentinterpersonalskillsand flexibility.

  • Advanced writing skills.

  • Proficient in running a great number of methods.

  • Apply acquired biopharmaceutical skills to projects and assignments.

Physical Requirements

  • Lifting up to 40 lbs.

  • Able to stand for extended periods of time.

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.

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