Location: Rochester,NY, USA
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 Microbiologist II 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.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Job Description
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.
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.
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.