Collegium Pharmaceutical

Senior QA Specialist

Job Locations US-MA-Stoughton
Posted Date 1 month ago(7/5/2022 8:54 AM)
ID
2022-1534
# of Openings
1
Category
Regulatory Affairs & Quality Assurance

Overview

At Collegium Pharmaceutical, we are building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a portfolio of meaningfully differentiated medications to treat serious medical conditions, including moderate-to-severe pain and acute migraine.

 

The QA Senior Specialist receives, logs, analyzes and reconciles product quality complaints and is the subject matter expert for day to day processing issues. Utilizes sound judgement to develop and recommend solutions to a variety of moderately complex quality events and issues related to the complaint management process. Investigates process related failures using the deviation system and implements CAPAs when appropriate. Conducts QA duties in compliance with SOPs, cGMP’s and in accordance with company policies, procedures, and federal regulations.  In addition, this role will occasionally support other Quality activities related to Change Control, Training, Annual Product Review, etc… in order to maintain compliance with all aspects of 21CFR §210, §211, and §820 cGMP.

 

Persons applying for employment with Collegium Pharmaceutical on and after August 1, 2021, who are offered a position are expected to be able to provide proof of vaccination against COVID-19 prior to their start date as permitted under state law, unless they seek and are approved for an exemption by Collegium as a reasonable accommodation based on bona fide religious or medical grounds.

 

Responsibilities

  • Ensures complaints are processed as required by SOPs as well as cGMP regulations.
  • Performs and oversees the daily Product Complaint processing activities including: complaint initiation, due diligence, investigation assignment, investigation closure, complaint closure, and the identification of potential Quality risks and/or trends for escalation to management.
  • Liaise with vendors’ (Contract Manufacturing Organizations, Contract Testing Laboratories, etc.) Quality Assurance departments
  • Assist in continuous improvement initiatives.
  • Assist with FDA inspections, other regulatory inspections and audits .

Qualifications

  • Bachelor’s degree in relevant field required
  • 2-4 years of experience in Quality Assurance, Quality Control, Regulatory, or Manufacturing in Pharmaceutical or Biologics required
  • Strong interpersonal and organizational skills
  • Demonstrated knowledge of cGMPs
  • GCP experience and/or controlled substance experience a plus

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