QC Analyst II - Microbiology

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 – Microbiology will perform microbiological testing, release of in-process, intermediates and finished products, and testing for validation purposes. This role is responsible for authoring new SOPs and/or revising of existing documentation. Additionally, this role is responsible for writing Deviation Investigations, Laboratory Assessments, and Investigation Reports.

Job Description

Responsibilities:

Sample Collection & Testing

• Conducts routine and non-routine analysis of environmental samples, raw materials, in process, and finished products according to standard operating procedures (SOPs).
• Reports identified abnormalities to QC Management for resolution and response.
• 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.

Technical Writing

• Authors new SOPs and/or revises existing documentation.
• Responsible for writing Deviation Investigations (DI’s), Laboratory Assessments (LA’s), and Investigation Reports (IR’s).

Instrument Maintenance

• Calibrates and maintains laboratory equipment according to SOPS.

GMP Compliance

• Applies knowledge of Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.
• Adheres to Company safety procedures and guidelines on a daily basis.

Qualifications:

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.
• Microbiology testing experience in a pharmaceutical or biotechnology industry required.
• General experience in a development, quality, or manufacturing environment preferred.

Knowledge

• Working knowledge of microbiology testing (i.e., USP Purified Water, WFI, Nitrogen, Compressed Air, Environmental Monitoring, bioburden, endotoxin, TOC).
• General knowledge of cGMP practices, ICH requirements, stability and validation.

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 project and assignments.

Physical Requirements

• Lifting up to 40 lbs.
• Able to climb ladder for sampling.
• Able to stand for extended periods of time.
• Ability to wear a sterile gown and don shoe covers on a periodic basis.

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.