Validation Associate
- Job Title
- Validation Associate
- Job ID
- 27747353
- Location
- Mainland, PA, 19451
- Other Location
- 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.
