Temporary Manufacturing Compliance Specialist I - Located at Fall River, MA | GenomeWeb

Temporary Manufacturing Compliance Specialist I - Located at Fall River, MA

Organization
University of Massachusetts Medical School
Job Location
Mattapan, MA 02126-3120
Job Description

GENERAL SUMMARY OF POSITION:

 

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

 

THIS POSITION IS LOCATED IN FALL RIVER, MA.

Requirements

MAJOR RESPONSIBILITIES:

 

  • Analyzes routine manufacturing deviations to determine root cause and writes final investigatory report. Assists in the analysis and reporting of complex deviations. Assists in implementation of any corrective actions.
  • Writes change controls. Proposes and drafts changes to SOPs.
  • Prepares batch records and conducts initial batch record review.
  • 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. Trends manufacturing parameters. Tracks tasks and CAPAs.
  • Performs 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.
  • Performs additional job related duties as required.

REQUIRED QUALIFICATIONS:

 

  • Requires a bachelor's degree with a minimum 5 years of relevant experience or equivalent
  • Ability to follow instructions precisely , recognize deviations, and recommend corrective action
  • Prior experience in a cGMP regulated environment is required. Strong working knowledge of 21 CFR Part 210 & 211 required
  • Demonstrated ability to train 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
  • Experience in pharmaceutical and biologics manufacturing preferred
  • Ability to lift up to 50 lbs with proper lifting technique.

SUPERVISION RECEIVED:

Reports to Manufacturing Compliance Manger

 

SUPERVISION EXERCISED:

None

 

ENVIRONMENTAL WORKING CONDITIONS:

Job may require working with hazardous and infectious materials. Employees will receive appropriate training and be required to adhere to UMBL policies and procedures.

 

THIS POSITION IS LOCATED IN FALL RIVER, MA.

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