AMRI Validation Specialist in Springfield, Missouri

The QA Validation Specialist, assists with the validation activities throughout the plant, coordinates appropriate support, assists in completing validation activities, and provides technical assistance to Engineering, R&D, Production, Maintenance and QA/QC in Validation and Quality Assurance-related issues

MAJOR RESPONSIBILITIES/ACCOUNTABILITIES :

A. Essential functional duties of the position-

· Develop and maintain a thorough understanding of cGMPs and associated regulations. Apply this knowledge in the everyday work environment, providing consultation as necessary. Actively participate in resolving quality issues. Make suggestions for quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements.

· Assisting in cleaning, process and equipment validation activities throughout the plant. This includes coordinating validation and cGMP-related activities of Engineering Services, R&D, Production, Maintenance and QA/QC.

· Maintain validation procedures and appropriate documentation to support installation, operational, cleaning and performance testing.

· Review and approve change controls and qualification/validation documentation. Authorize equipment for use and product release.

· Provide training on validation issues and documentation.

· Communicate validation issues and requirements to plant personnel on a frequent basis through participation in Engineering, R&D and management staff meetings, and applicable project teams.

· Track all validation documentation throughout the plant and follow-up as needed.

· Participate in self-development activities and training of others.

· Exhibit safety awareness and safe work practices.

B. Other responsibilities/accountabilities-

· Perform other quality functions as necessary or as requested. Perform other duties as may be reasonably assigned in the course of business.

· Maintain awareness of current regulatory trends and practices. Assist in FDA and customer audits.

· Manage and complete each assigned Annual Product Review (APR). This includes cooperating transversally with various departments and to ensure that data is supplied on time and is sufficient and compliant with appropriate procedures.

· Review and approve deviations and investigations. Compile data, prepare and review trends. Identify areas of concern and communicate to management.

PREFERRED KNOWLEDGE/SKILL REQUIREMENTS:

· BS Chemical or Mechanical Engineering.

· Two to five years validation experience.

· Demonstrated interpersonal skills.

· Computer literate with a functional ability with word processing, spreadsheets, project scheduling, database and presentation software.

Language/Communication Skills

Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

Mathematical Skills

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.

Reasoning Ability

Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to read and verify engineering drawings.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand, walk, use hands to finger, handle, or feel, reach with hands and arms, climb or balance and stoop, kneel, crouch, and crawl. The employee may rarely lift and/or move up to 55 pounds. Specific vision abilities required in this job include close vision, distance vision, peripheral vision, color vision, depth perception and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job the employee is regularly required to work in a normal office environment and to enter the production area of a typical manufacturing facility which has moving mechanical parts, and may have fumes or airborne particles, extreme heat, wet and/or humid conditions, low levels of toxic or caustic chemicals, and outside weather conditions. The noise level in the environment is usually moderate.

The QA Validation Specialist, assists with the validation activities throughout the plant, coordinates appropriate support, assists in completing validation activities, and provides technical assistance to Engineering, R&D, Production, Maintenance and QA/QC in Validation and Quality Assurance-related issues

MAJOR RESPONSIBILITIES/ACCOUNTABILITIES :

A. Essential functional duties of the position-

· Develop and maintain a thorough understanding of cGMPs and associated regulations. Apply this knowledge in the everyday work environment, providing consultation as necessary. Actively participate in resolving quality issues. Make suggestions for quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements.

· Assisting in cleaning, process and equipment validation activities throughout the plant. This includes coordinating validation and cGMP-related activities of Engineering Services, R&D, Production, Maintenance and QA/QC.

· Maintain validation procedures and appropriate documentation to support installation, operational, cleaning and performance testing.

· Review and approve change controls and qualification/validation documentation. Authorize equipment for use and product release.

· Provide training on validation issues and documentation.

· Communicate validation issues and requirements to plant personnel on a frequent basis through participation in Engineering, R&D and management staff meetings, and applicable project teams.

· Track all validation documentation throughout the plant and follow-up as needed.

· Participate in self-development activities and training of others.

· Exhibit safety awareness and safe work practices.

B. Other responsibilities/accountabilities-

· Perform other quality functions as necessary or as requested. Perform other duties as may be reasonably assigned in the course of business.

· Maintain awareness of current regulatory trends and practices. Assist in FDA and customer audits.

· Manage and complete each assigned Annual Product Review (APR). This includes cooperating transversally with various departments and to ensure that data is supplied on time and is sufficient and compliant with appropriate procedures.

· Review and approve deviations and investigations. Compile data, prepare and review trends. Identify areas of concern and communicate to management.

PREFERRED KNOWLEDGE/SKILL REQUIREMENTS:

· BS Chemical or Mechanical Engineering.

· Two to five years validation experience.

· Demonstrated interpersonal skills.

· Computer literate with a functional ability with word processing, spreadsheets, project scheduling, database and presentation software.

Language/Communication Skills

Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

Mathematical Skills

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.

Reasoning Ability

Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to read and verify engineering drawings.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

/ /

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand, walk, use hands to finger, handle, or feel, reach with hands and arms, climb or balance and stoop, kneel, crouch, and crawl. The employee may rarely lift and/or move up to 55 pounds. Specific vision abilities required in this job include close vision, distance vision, peripheral vision, color vision, depth perception and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job the employee is regularly required to work in a normal office environment and to enter the production area of a typical manufacturing facility which has moving mechanical parts, and may have fumes or airborne particles, extreme heat, wet and/or humid conditions, low levels of toxic or caustic chemicals, and outside weather conditions. The noise level in the environment is usually moderate.

Job: *Quality

Organization: *AMRI Springfield

Title: Validation Specialist

Location: MO-Springfield

Requisition ID: 1002378

EOE Protected Veterans/Disability