Job Information
Endo International Sr Supervisor, Quality Chemistry in Rochester, Michigan
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
Directly supervises non-exempt and lower level exempt staff in the Quality Chemistry laboratory whose work is typically guided by established policies, practices and/or procedures. Demonstrates a high level of technical and functional business expertise to excel at coaching daily activities. With experience and competence, supervises a larger staff, handles more complex projects, and has greater responsibility. Mentor other supervisors. Administers and executes policies, processes, and procedures that affect subordinate employees and the workflow of the work unit (Finished Product, Raw Materials, Stability, or Validation). Handles special projects and initiatives that have greater impact on the business with ease. Interacts daily with subordinates and/or peers within similar or related functions primarily for the purpose of presenting and exchanging information. External interactions are typically with suppliers, vendors and/or customers. Increasingly, interacts with leaders in other departments to address problems and increase throughput and efficiency. Has thorough knowledge of, and stays current with, regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.
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 business location and function
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Leadership
Supervises a functional group (Finished Product, Raw Materials, Stability, or Validation)
Ensures that daily analyses are completed to support manufacturing and are compliant with requirements
Writes and reviews functional group trends in analysis, performance, and quality to maintain regulatory commitments and company standards of excellence.
Issues status reports and metrics of the group activities
Supervise group in staffing, work assignments, and employee counseling
Assists in the development and implementation of training as require to ensure staff meets all requirements
Mentors other supervisors
Interacts with leaders in other departments to address problems and increase throughput and efficiency.
60%
Trouble
Shooting
- Assists chemists with troubleshooting of instrumentation, analysis, and methodologies
10%
Investigations
- Conducts OOS/OOT investigations per established SOPs and in compliance with regulatory commitments.
10%
Compliance
Has thorough knowledge of, and stays current with, regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing
Review and compare regulations and compendial requirements against SOPs and methods to ensure compliance
Ensure GMP. Compendial, CFR, and company SOPs are adhered to as required.
Follows internal processes related to controlled substances
continuous
Training
- May train Chemist I, II & III, and Senior Chemists on analyses
10%
SOPs
- Assist and/or initiate change controls for procedures, methodologies, and specifications as needed
10%
Safety
- Follows EH&S procedures to ensure a safe work environment
continuous
Other
- Other duties as assigned
continuous
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- BS in Chemistry plus 5 or more years prior supervisory experience, including 2-3 years’ experience as a Supervisor, Quality Chemistry in a tablets Laboratory
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.
Has advanced knowledge of laboratory software and has expanded knowledge of chromatographic software, using custom fields, custom calculations and custom reports
Has thorough knowledge of, and stays current with, regulatory guidances and compendia relevant to laboratories and pharmaceutical mfg.
Competency in Microsoft Office Suite
Proficient in reading and writing English
Advanced chemistry techniques
General chemistry safety
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 communication skills, including reading and understanding technical instructions
Ability to collaborate and develop effective working relationships
Good attention to detail
Solid organizational skills
Ability to coach and develop laboratory skills and abilities
Ability to interact with all levels of the organization
Ability to effectively resolve conflict
Ability to take initiative, set priorities and follow through on assignments
Ability to critically review, analyze, and interpret information and draw conclusions from relevant or missing information
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.
Ability to stand for up to 8 hours
Ability to tolerate warm, humid environments for short periods such as would be experienced in an accelerated stability chamber
Ability to wear personal protective equipment, including respirators, gloves, etc.
Manual dexterity
Ability to lift and carry 15lbs
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.
Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.