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Manufacturing Compliance Specialist II
Job Number: 2019-32477Category: 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
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