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 Supervisor, Microbiology oversees day-to-day operations of the Microbiology group. Ensures compliance with cGMP’s and GLP’s while conducting investigations. Support all sites QC and AR&D (sampling, validation and routine testing, special projects, etc.) for Microbiology and Technical issues.
Job Description
Scope of Authority
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Microbiology supervision within a single site.
Key Accountabilities
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Microbiology Lab Supervision
- Oversee day-to-day operations of the Microbiology Lab to ensure that cGMPs, GLP’s and all other applicable compendia requirements are met.
- Scheduling of the samples to be tested, reviewing of analyst’s notebooks/LIMS data and ensuring testing is done per the approved procedures, timely generation of release data of the samples tested.
- Investigate Alert/Questionable/OOS test results and take corrective actions, document investigation findings and coordinate the approval process of investigations in TrackWise.
Compliance
- Develop procedures for an environmental monitoring program to ensure cGMP compliance (air sampling, surface testing, swab sampling) from the Microbiological testing perspective. Microbiological limit testing, preparation testing, validation of new equipment and overseeing and troubleshooting the identifications done by Vitek system.
SOPs
- Review and update SOP’s and procedures for the QC Group as needed. Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums and oversee maintenance, logbooks, and expiration dating of stock cultures, media and sterilization documents.
- Develop and validate microbiological test procedures for purified water systems, API’s, excipients, finished dosage forms, stability and AR&D samples.
Staff Development
- Evaluate potential candidates for QC and conduct performance evaluations of direct reports.
Qualifications
Education & Experience
- BS in a scientific discipline or equivalent with 7+ years’ relevant experience required. Advanced degree a plus.
- 2+ years’ in a lead and/or senior level role in a Quality Microbiology lab.
Knowledge
- Familiarity with Drug GMP regulations.
- Strong knowledge of Microbiology and expanded knowledge of Pharmaceutical Microbiology.
- Knowledge of, and stays current with, regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.
- Proficient with laboratory computer software used for stability.
- Competency in Microsoft Office Suite.
- General Laboratory safety, including Biohazard safety.
Skills
&
Abilities
- Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things.
- Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives; supports everyone's efforts to succeed.
- Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.
- Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
- Demonstrate ability to communicate effectively in a team environment.
- Demonstrate flexibility in carrying out a variety of assignments in a high quality work environment.
- Ability to complete assigned task with minimum supervision.
Physical Requirements
- The noise level in the work environment is usually moderate.
- The work environment is representative of a group laboratory environment.
- While performing the duties of this job, the employee is frequently required to use hands to finger, handle, or feel. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.
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.
