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.
Job Description Summary
Responsible for laboratory and equipment cleanliness, routine physical and chemical testing per SOPs, and, with guidance, detects and participates in OOS/OOT and other investigations. Tracks Small Equipment Inventory in support of metrology activities for calibration, maintenance, repair, retirement and disposal. Interface with laboratory vendors regarding purchasing, sourcing of materials, reagents, USP standards and USP Group A defined lab equipment. May learn the Non-Conformance Reporting (NCR) process including root cause and gap analysis. Become knowledgeable of industry regulations, guidance’s and compendia as it relates to job function.
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
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
General Lab Support
- Maintains the cleanliness of glassware by operating glassware washers or hand washing
- Identifies materials needed for resupply
- Performs laboratory housekeeping
- Disposes of laboratory materials in accordance with EH&S and DEA procedures
- Orders, receives, and logs reference standards, chemicals, supplies, and consumables such as HPLC columns
- Receives manufacturing samples for controlled and non-controlled products, distributes to chemists, and processes product waste
- Performs instrument log book and analyst project notebook creation/archive
- Becomes Qualified Trainer and train Quality Technicians I
- Maintains laboratory metrics and assists with statistical analysis for cost saving measures of the laboratory
- May train Quality Technicians I & II as it relates to job function
- May learn technician competency in either Quality Materials or Quality Labeling
- Interfaces with laboratory vendors regarding purchasing, sourcing of materials, reagents, USP standards and USP Group A defined lab equipment
- Supports instrument accessory replacement
50%
Infrastructure Support
- Receives and maintains consumables such HPLC columns
- Orders, receives and maintains controlled reference standards and samples
- Logs samples into LIMS for testing
- Receives and logs reference standards, samples, chemicals, and supplies
25%
Analysis & Testing
- Performs minor, routine physical and chemical analyses per SOPs
- With guidance, detects and participates in OOS/OOT and other investigations
15%
Calibrations and Maintenance
- Performs routine HPLC Column maintenance, rejuvenation and inventory
- Assists Metrology and Laboratory personnel with qualification processes for new instrument installation
10%
Compliance
- Understands and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing
- Follows internal processes related to controlled substances
- Tracks Small Equipment Inventory in support of metrology activities for calibration, maintenance, repair, retirement and disposal
- Performs documentation archive, retrieval, and audits
- Reviews laboratory SOPs regarding technician functions to ensure accuracy and relevance
- Maintains and tracks verification tools and small instruments (dissolution, pH meters, timers, thermometers, stir plates, shakers, etc.)
- May learn the Non-Conformance Reporting (NCR) process, including root cause and gap analysis
- Becomes knowledgeable of industry regulations, guidance’s and compendia as it relates to job function
continuous
Safety
Follows EH&S procedures to ensure a safe work environment
continuous
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- High school diploma or equivalent with 4-7 years’ relevant experience OR
- AA/AS with 3-6 years’ relevant experience OR
- BA/BS in related discipline with 2-5 years’ relevant experience
- Related discipline, & certification in assigned area, as required
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.
- Strong understanding of regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing
- 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.
- Good communication skills, including reading and understanding technical instructions
- Good attention to detail
- Solid organizational skills
- Ability to take initiative, set priorities and follow through on assignments
- Is competent in standard Microsoft Office software as well as COUPA for ordering supplies
- Proficient in the use of the Laboratory Information Management System (LIMS)
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 wear personal protective equipment, including respirators, gloves, etc.
- Manual dexterity
- Ability to lift and carry 25 lbs.
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.
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.