Associate Quality Specialist, Stability

Endo; Rochester (MN); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company in the healthcare sector is seeking an Associate Quality Specialist to execute the stability program. This role involves monitoring stability samples, maintaining documentation, and ensuring compliance with FDA regulations. The ideal candidate will possess a BS in Chemistry and demonstrate strong communication and teamwork skills. Join a dedicated team committed to delivering life-enhancing products and supporting each other's success.

Qualifications

• 0+ years of experience in pharmaceutical or related industry.
• Familiarity with Drug GMP regulations.

Responsibilities

• Monitor manufacturing schedules and prepare stability lot schedule.
• Initiates stability studies in LIMS and maintains tracking database.
• Collects data for regulatory reporting.

Skills

Flexibility

Oral Communication

Written Communication

Teamwork

Quality

Education

BS in Chemistry

Tools

Microsoft Office Suite

Job description

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 Associate Quality Specialist, Stability is responsible for executing the stability program under direction from senior colleagues and/or management. This includes stability study receipt and incubation, along with maintaining appropriate cGMP documentation. This position will have a role in initiating and participating in records in the Quality Management System (e.,g., Change Records, Investigations, CAPA).

All incumbents are responsible for following applicable Division & Company policies and procedures.

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.

Scope is the global stability program, with work performed at Rochester site.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Stability

• Monitor manufacturing schedules daily as provided. Identifies stability lots and prepares a weekly stability lot schedule to sample receipt team.
• Receives, labels, and incubates new stability samples of submission, validation, pilot, experimental and annual commitment batches according to the protocol
• Initiates stability studies in LIMS per applicable SOPs
• Maintains applicable database for tracking pending stability lots.
• Communicates within and across departments to ensure stability lots are received and incubated in a timely manner.
• Monitors inventory of samples in the stability chambers
• Prepares chamber capacity metrics on monthly basis and provides to management.
• Completes training for review of stability data and identification of potential trends.
• Initiates Change Records for the Stability Program in accordance with applicable SOPs.
• Participates in Change Records, Investigations, CAPAs for the Stability Program
• Provides input as part of the team for making updates to SOPs or other cGMP documents as necessary
• Builds stability templates in LIMS per applicable SOPs.
• Supports the transfer/shipping of stability samples to alternate testing site.
  
  

80%

FDA Reporting

• Collects data for regulatory reporting (e.g., Annual Report).
  
  

20%

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• BS in Chemistry or related discipline with 0+ years of experience in pharmaceutical or related industry
  
  

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.

• Familiarity with Drug GMP regulations
• Experience with Microsoft office suite software, to include Excel.
  
  

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.

• Demonstrate flexibility in carrying out a variety of assignments in a high quality work environment
• Ability to complete assigned task with oversight from senior colleagues and management.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings
• Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information
• 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
• Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality
  
  

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.

• Noise level in the work environment is usually moderate
• Work environment is representative of a group laboratory environment
• Frequently required to use hands to finger, handle, or feel
• Occasionally lift and/or move up to 25 pounds
  
  

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.