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Manufacturing Compliance Associate I
Job Number: 2019-33071
Category: Biotechnology
Location: Mattapan, MA
Shift: Day
Exempt/Non-Exempt: Non Exempt
Business Unit: MassBiologics
Department: MassBiological Labs - MassBiologics of UMMS - W416800
Job Type: Full-Time
Salary Grade: 04
Union Code: Non Union Position-W25-Non Unit Classified
Num. Openings: 1
Post Date: May 31, 2019

GENERAL SUMMARY OF POSITION:

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

MAJOR RESPONSIBILITIES:

 

  • Assists with routine manufacturing deviations to determine root cause and writes final investigatory report. Assists in the analysis and reporting of deviations. Assists in implementation of any corrective actions.
  • Assists departments in updating SOP’s, Batch Records and In-Process Forms.
  • Assists with batch record review
  • Coordinates with Quality Assurance to ensure that incident/deviations, planned deviations, and change controls are closed in a timely manner.
  • Updates SOP manuals to ensure manuals are up to date.
  • Maintain process records and logs. Assists in trending manufacturing parameters..
  • Assists in the performance of internal audits.
  • Performs additional job related duties as required.

REQUIRED QUALIFICATIONS:

 

  • Requires a bachelor’s degree in a scientific discipline, preferably biology with a minimum 0-2 years of relevant experience or equivalent
  • Ability to follow instructions precisely , recognize deviations, and recommend corrective action within scope of training
  • Ability to adapt to a cGxP regulated environment
  • Ability to troubleshoot within scope of training
  • Computer literate and proficient in MS Word, Excel and other relevant electronic systems
  • Strong time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines
  • Ability to apply scientific and technical principles to problem solving
  • 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 with others
  • Demonstrated initiative through past experience
  • Ability to work effectively both independently and as a member of a team
  • Experience in the following areas is required: aseptic gowning

PREFERRED QUALIFICATIONS:

 

  • Experience in the following areas is preferred: manufacturing

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