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ENDO
Horsham, PA | Full Time
$67k-88k (estimate)
4 Months Ago
QC Analyst II - Chemistry
ENDO Horsham, PA
$67k-88k (estimate)
Full Time | Business Services 4 Months Ago
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ENDO is Hiring a QC Analyst II - Chemistry Near Horsham, PA

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 SummaryThe 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.
ResponsibilitiesJob DescriptionQC
Testing/Safety
  • Testing responsibilities may include RP-HPLC, SEC, KF, FT-IR, SDS-PAGE, and UV-Vis.
  • Adheres to Company safety procedures and guidelines on a daily basis.
Documentation
  • Completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.
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
  • Other duties as assigned 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.
  • General experience in a development, quality, or manufacturing environment preferred.
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 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.
  • 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.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$67k-88k (estimate)

POST DATE

05/28/2024

EXPIRATION DATE

10/02/2024

HEADQUARTERS

SAINT-CYR-AU-MONT-D'OR, AUVERGNE-RHONE-ALPES

SIZE

200 - 500

FOUNDED

2019

CEO

ROSARIO IROUDAYARADJE SOUNDRON

REVENUE

$10M - $50M

INDUSTRY

Business Services

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