Sr Quality Associate, Materials Position Available In Monroe, New York

Sr Quality Associate, Materials Sr Quality Associate, Materials locations
Rochester, Michigan
time type
Full time
posted on
Posted 3 Days Ago
job requisition id
R002439 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 The Senior Quality Associate, Materials is responsible for performing procedures related to sampling and inspection of raw materials, packaging components and water to ensure conformance to specifications. Participates in resolving complex issues. Trains lower level Quality Associates, Materials. 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. Responsible for sampling and inspecting materials and water at a single site Key Accountabilities
• key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Sampling Is competent in all applicable procedures and sampling SOPs
  Is competent in and can perform all sampling process (raw materials, components, and water)
  Is competent as an Associate in labeling or the laboratory
  Coordinates with the warehouse to retrieve materials required for inspection and sampling
  Samples materials and accurately completes associated documentation
  Samples purified water, as required, and submit for testing
  Cleans sampling rooms and equipment
  Properly handles and submits material retains to the archive storage 30% Inspection & Analysis Examines materials and components to ensure conformance to specifications
  Confirms material identity and quantity through visual inspection against supplier/internally provided documentation and CoA
  Performs minor physical analyses per SOPs
  Initiates change control for SOPs and specifications 30% Problem Solving & Training Participates in resolving complex issues
  Ability to train junior Quality Associates as a Qualified Trainer 20% Compliance Participates in gap analysis and recommends revisions to SOPs
  Follows internal processes related to controlled substances
  Initiates vendor complaints
  Participates in NCR process 10% Continuous Improvement As needed, participates as a Quality representative on process excellence initiatives, Kaizen events, and special projects
  Participates in investigations with the Investigation Team as needed
  Assist supervisor in scheduling and represents department in cross functional meetings
  As needed, leads work groups or projects
  Demonstrates advanced computer competency to perform daily tasks (e.

g.

LIMS, ERP

system, TrackWise, Word and/or Excel) 10% Quality Issues Responds to and escalates events Continuous Safety Follows EH&S procedures to ensure a safe work environment
Other duties as assigned 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 6-10+ years’ relevant experience OR
AA/AS degree plus 5-9 years’ relevant experience OR
BA/BS degree plus 4-8 years’ relevant experience
Related discipline and certification in assigned area a plus 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. Thorough knowledge of relevant cGMP regulations and processes 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 learn and perform Quality Operations tasks
Is competent in all applicable procedures & sampling SOPs
Is competent in and can perform all sampling process (raw materials, components, and water)
Basic math, writing skills, and problem solving abilities 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. Must be able to stand for long periods of time (up to 8 hour shifts), lift at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes
Dexterity

• ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects
  Vision
• Vision should be correctable to 20/20
  Hearing
• ability to detect or tell the differences between sounds that vary in pitch and loudness
  Multi-limb Coordination
• ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing

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.