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 III - 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 provides support to the QC team involved with raw material testing, in-process manufacturing support, and drug substance/drug product testing. Additionally, the Analyst III will act as a technical liaison between Quality Control (QC) and outside departments and contractors/subsidiaries.

Job Description

Responsibilities:

QC Testing/Safety

Supports the QC team involved with raw material testing, in-process manufacturing support, and drug substance/drug product testing.

Adheres to Company safety procedures and guidelines on a daily basis.

Technical Writing & Investigations

Performs OOS investigation and resolution, deviation response, and resolution.

Prepares new SOPs / test methods and/or revises existing documentation.

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

Data Review

Reviews data obtained for compliance to in-process limits and specifications.  Reports abnormalities to senior management.

Documentation

Completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.

Technical Development

Develops assays to support raw materials testing and the QC release testing and stability program. Method optimization, implementation, and validation.

Technical Transfer

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

Instrument Maintenance

Performs maintenance, calibration, and validation of instruments and equipment.

GMP Compliance

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

Technical Support

Acts as technical liaison between QC and outside departments or contractors / subsidiaries.

Other Tasks

Other duties as assigned by QC management.

Qualifications:

Education & Experience

B.S. in a Biological Science or related field with a minimum of 5-7 years’ experience in pharmaceutical or biotechnology industry required OR

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

Analytical testing experience in a pharmaceutical or biotechnology setting required.

Working experience in analytical method development and validation for both small molecules and protein products is highly desirable.

Knowledge

Deep 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).

General knowledge of cGMP practices, ICH requirements, stability, and validation required.

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

Skills & Abilities

Strong verbal and communication skills required.

Proficient in common software applications.

Ability to handle multiple priorities in a fast-paced environment.

Demonstrates excellent interpersonal skills and flexibility.

Applies critical thought to solving problems of complex scope.

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.