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GENERAL SUMMARY OF POSITION:

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

MAJOR RESPONSIBILITIES:

• Analyzes 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.
• 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.
• Updates SOP manuals to ensure manuals are up to date.
• Maintain process records and logs. Trends manufacturing parameters. Tracks tasks and CAPAs.
• Assists in the performance of internal audits.
• Maintains training logs in accordance with GMP.
• Performs additional job related duties as required.

REQUIRED QUALIFICATIONS:

• Requires a bachelor’s degree
• Minimum 2years of relevant experience or equivalent
• Ability to follow instructions precisely , recognize deviations, and recommend corrective action
• 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
• Ability to work effectively both independently and as a member of a team

PREFERRED QUALIFICATIONS:

• Prior experience in a cGMP regulated environment
• Strong working knowledge of 21 CFR Part 210 & 211
• Experience in pharmaceutical and biologics manufacturing