Share This Page
Explore the Possibilities
and Advance with Us.
Manufacturing Compliance Specialist II
Job Number: 2019-32477
Category: Biotechnology
Location: Mattapan, MA
Shift: Day
Exempt/Non-Exempt: Exempt
Business Unit: MassBiologics
Department: MassBiological Labs - MassBiologics of UMMS - W416800
Job Type: Full-Time
Salary Grade: 45
Num. Openings: 1
Post Date: March 4, 2019

MassBiologics%20Letterhead%20logo%20(JPG) (2)

GENERAL SUMMARY OF POSITION: 

 

The Manufacturing Compliance Specialist II is responsible to ensure that manufacturing processes are performed and documented in compliance GMP and established SOPs.

MAJOR RESPONSIBILITIES:

  • Analyzes routine and complex manufacturing deviations to determine root cause.  Writes final investigatory reports for manufacturing deviations.  Implements corrective actions.
  • Writes change controls. Writes and revises SOPs.
  • Ensures that batch records are properly prepared for handoff to Quality Assurance
  • Coordinates with Quality Assurance to ensure that incident/deviations, planned deviations, and change controls are closed in a timely manner.
  • Provides input to validation protocols and coordinates their execution.
  • Reviews CMMS work orders for completion.
  • Maintain process records and logs.  Tracks tasks and CAPAs. Analyzes manufacturing trends and develops trend reports.
  • Leads internal audits.
  • Trains employees on manufacturing procedures, equipment operations and maintenance, cleaning protocols, calibration of equipment and GMP. Maintains training logs in accordance with GMP.
  • May supervise lower level personnel.
  • Performs additional job related duties as required.

REQUIRED QUALIFICATIONS:

  • Requires a bachelor’s degree with a minimum 6 years of relevant experience or equivalent
  • Ability to follow instructions precisely , recognize deviations, and recommend corrective action
  • Prior experience in a cGMP environment is required. Strong working knowledge of 21 CFR Part 210 and 211 required
  • Demonstrated ability to train and supervise others
  • Ability to conduct complex troubleshooting 
  • Computer literate and proficient in MS Word, Excel and other relevant electronic systems
  • Strong critical thinking, time management and organizational skills.  Demonstrated ability to multitask and consistently meet deadlines
  • Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills.
  • Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others 
  • Demonstrated initiative through past experience
  • Ability to work effectively both independently and as a member of a team
  • Ability to lift up to 50 lbs using proper lifting technique

Check Out Our Advancing Careers 
HR Blog

UMass Chan Medical School was among 23 companies that stood out as 2023 “DEI champions,” according to The Boston Globe.   


Named a U.S. News & World Report
“2023 BEST MEDICAL GRAD SCHOOL”
for Primary Care and Research