What are the responsibilities and job description for the Chemist II, Quality Control Laboratory position at Endo International?
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 Chemist II, under general supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. Detects, participates and reports on OOS / OOT / NOE and other investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. May train less senior staff.
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
Analysis & Testing
- Conducts laboratory analyses : finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer / solution preparation, standard preparation and operating analytical instruments : HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
- Uses laboratory software for analyses
- May review and approve laboratory test data and documentation for completeness and compliance
- Is alert to and detects abnormalities during performances of tests and reviews
- May perform lab methods transfer and participate in method validation / verification studies
Lab Equipment
Investigations
Training
Compliance
continuous
Safety
continuous
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
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.
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.
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.
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.