What are the responsibilities and job description for the Validation Associate position at Accupac?
Description
Essential Functions of the Job :
Maintain the Company's compliance with established Accupac, LLC. Standard Operating Procedures, FDA Current Good Manufacturing Practices, and the Customer's specifications.
Establish performance and quality criteria. Create and run quality tests based on appropriate protocols.
Ensure compliance with safety and quality standards.
Strong understanding of manufacturing, packaging, and cleaning processes and safety regulations.
Ensure products meet company requirements by writing protocols and creating a documented trail of results for both manufacturing and packaging processes.
Strong documentation bias - managing and documenting the entire validation process. The protocols produced must comply with both internal SOPs and external regulations.
Perform Equipment IQ / OQ and Gap analysis.
Review all questions, errors, and deviations with the respective departmental Management and QA and resolve issues.
Maintain the completed validation documentation and all associated data.
Maintain open communication with Project Management and Operations for validation requirements.
Maintain Calibration Management database including entering, changing, and updating equipment status in the Calibration Manager database.
Provide PM and Calibration documentation to either internal or external personnel.
Provide oversight on the timely completion of PMs and Calibrations.
Review completed validation, PM, calibration documentation for accuracy and GMP compliance.
Performs other related duties as required and assigned.
Minimum Requirements of the Job :
Possess effective time management and organizational skills.
Possess a working knowledge of liquid / semi-solid manufacturing, packaging, and cleaning processes.
Experience with equipment and facility validation protocols and (IQ / OQ / PQ)
Ability to read, write, speak, and comprehend the English language.
Ability to perform mathematical functions (add, subtract, multiply, divide and use of percentages) with whole numbers and decimals.
Understand Metric equivalents of US measurements (grams / ounces : kilograms / pounds : liters / gallons).
Must be a self-starter and require minimal supervision.
Possess a working knowledge of Microsoft Word, Windows, Excel, and Power Point.
Present a neat and professional appearance that displays confidence and maturity.
Conduct oneself in a professional manner.
Comply with all company policies, SOP's, current Good Manufacturing Practices, and other relevant regulatory requirements.
Maintain training at or above 90% of assigned curriculum.
Attention to detail.
Physical Requirements :
Ability to stand / sit for long periods of time.
Ability to lift and carry items up to forty (40) pounds.
Possess peripheral vision.
Supervisory Responsibilities : No
Travel : None
Education and / or Experience : For a Validation Associate I a B.S College degree is preferred or a minimum of 1-2 years of experience in a cGMP regulated industry (validation experience preferred). For a Validation Associate II a B.S Degree is preferred and a minimum of 2-4 years of experience in validation in a cGMP regulated industry.
Required Skills
Essential Functions of the Job :
Maintain the Company's compliance with established Accupac, LLC. Standard Operating Procedures, FDA Current Good Manufacturing Practices, and the Customer's specifications.
Establish performance and quality criteria. Create and run quality tests based on appropriate protocols.
Ensure compliance with safety and quality standards.
Strong understanding of manufacturing, packaging, and cleaning processes and safety regulations.
Ensure products meet company requirements by writing protocols and creating a documented trail of results for both manufacturing and packaging processes.
Strong documentation bias - managing and documenting the entire validation process. The protocols produced must comply with both internal SOPs and external regulations.
Perform Equipment IQ / OQ and Gap analysis.
Review all questions, errors, and deviations with the respective departmental Management and QA and resolve issues.
Maintain the completed validation documentation and all associated data.
Maintain open communication with Project Management and Operations for validation requirements.
Maintain Calibration Management database including entering, changing, and updating equipment status in the Calibration Manager database.
Provide PM and Calibration documentation to either internal or external personnel.
Provide oversight on the timely completion of PMs and Calibrations.
Review completed validation, PM, calibration documentation for accuracy and GMP compliance.
Performs other related duties as required and assigned.
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