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Manufacturing Compliance Associate I
Job Number: 2019-33071Category: 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