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Validation Associate

3 months ago

Lakewood, United States Accupac Full time
Job DescriptionJob Description

Title: Validation Associate

Location / Department: Validation Department

Reports To: Validation Manager

________________________________________________________________________

Basic Job Functions:

The Validation Associate is responsible for ensuring calibration and maintenance activities performed internally and externally are performed as scheduled. Maintaining validation documentation such as Standard Operating Procedures (SOP), Calibration Forms, Preventive Maintenance Forms, Super Clean Forms, IOQ protocols, and other Process Validation documentation. Additionally, the Validation Associate is responsible for creating manufacturing and packaging process performance qualification protocols , cleaning validations and verification protocols, and equipment installation and operational qualification protocols.

Essential Functions of the Job:

  1. Review, write, and execute manufacturing, packaging, and cleaning protocols

  1. Review, write, and execute equipment IQ/OQ/PQ documentation.

  1. Perform Equipment Gap analysis.

  1. Assist with equipment/instrument usage, maintenance, repairs, and other mechanical issues and write/review/maintain all associated documentation.

  1. Maintain/review Equipment Calibration/ Preventative Maintenance Schedule.

  1. Enter, change, and update equipment status in Calibration Management database.

  1. Provide Preventive Maintenance and Calibration documentation to either internal or external personnel.

  1. Provide oversight on the timely completion of PMs and Calibrations.

  1. Perform/review in-house calibrations.

  1. Send equipment off site for calibrations or PMs as needed.

  1. Revise and review SOP’s.

  1. Maintain completed validation documentation and all associated data.

  1. Review all questions, errors, and deviations with the respective departmental Management and QS and resolve issues.

  1. Review completed validation, PM, calibration documentation for accuracy and GMP compliance.

  1. Maintain open communication with Project, Quality, and Operations Management for validation requirements.

  1. Maintain the Company’s compliance with established Accupac, Inc. Standard Operating Procedures, FDA Current Good Manufacturing Practices, and Customer’s specifications.

  1. Performs other related duties as required and assigned.

Minimum Requirements of the Job:

  1. Possess effective time management and organizational skills.

  1. Possess a working knowledge of liquid/solid manufacturing and packaging process.

  1. Experience with validation and IQ/OQ/PQ protocols

  1. Ability to read, write, speak and comprehend the English language.

  1. Ability to perform mathematical functions (add, subtract, multiply, divide and use of percentages) with whole numbers and decimals.

  1. Understand Metric equivalents of US measurements (grams/ounces: kilograms/pounds: liters/gallons).

  1. Must be a self-starter and require minimal supervision.

  1. Possess a working knowledge of Microsoft Word, Windows, Excel, and Power Point

  • Comply with all company policies, SOP’s, current Good Manufacturing Practices and other relevant regulatory requirements.

  • 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: A Validation Associate must have a B.S College degree in science or engineering or have appropriate previous validation experience. A minimum of 2 - 4 years of experience in a cGMP regulated industry and 1- 2 years of experience in validation is preferred.