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QA Document Control Manager

Date: May 3, 2021

Location: West Haven, CT, US, 06516

Company: Glanbia

QA Document Control Manager

 

POSITION PURPOSE: 

Implement and maintain the document control system for all documents that define product specifications and control manufacturing processes to ensure conformance to customer requirements, FDA, and third party certifications.  Ensure compliance to all food safety and quality regulations that apply to Watson.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

    • Manage the document control system to ensure conformance to customer’s requirements, food safety, regulatory and GFSI.
      • Responsible for leading the BRC team and internal audit program.
      • Documents include but are not limited to the following:
        • Watson Standard Operating Procedures (SOP’s);
        • Watson Analytical Lab Procedures (WAP’s);
        • Operations Work Instructions (WI’s);
        • Internal audit and customer audit follow up/corrective action;
        • Sanitation documents;
        • Organic certification documents;
        • Watson internal and external documents identified by management;
        • Others as needed
    • Manage the approval and copy control process of the document control system.
    • Maintain a comprehensive filing system and computer database for all documents to be retained.
    • Manage the operation of the document control center to ensure that all users have the latest revision of appropriate documentation in a timely manner.
    • Ensure that obsolete documentation is removed from distribution.
    • Sign SOP’s as needed.
    • Collect, file and maintain documentation at the latest revision level necessary to define product configuration and control manufacturing processes.
    • Assist in the development, implementation, and maintenance of company quality systems.
    • Responsible for maintaining the GFSI certification, Gluten-free certification, Organic certifications, and other as needed.
    • Support Quality Assurance group activities.
    • Maintain knowledge of appropriate standards, organizations, certification bodies, etc. to support as necessary.
    • Perform duties as defined in division document control policies and procedures.
    • Assists in investigations of returned goods, deviations, failures, and customer complaints.
    • Completes additional tasks and projects as assigned by management.
    • Perform mock recalls and mass balance.
    • Support customer audits and third party audits as required.
    • Ensure all reports, corrective actions and responses completed in a timely manner for all audits.
    • Maintain knowledge of FSMA, HARPC, FDA and other agencies as required.
    • Maintains up to date knowledge of industry quality trends
    • Write and maintain the Watson Quality Manual.
    • Create quarterly QE trending reports and present at management meetings.
    • Report on Quality KPI’s as required.
    • Support ERP and other software programs as required.

 

EDUCATION AND EXPERIENCE:

  • Minimum Associates degree, Bachelors degree preferred.
  • Work experience in a manufacturing environment – ingredient, reagent, pharmaceutical, or other process manufacturing.
  • Quality assurance and or quality control work experience in food science; bioscience; pharmaceutical or closely related field or a combination of certification and actual work experience in GLP/GMP environment is highly desirable.
  • Minimum 5 years experience in documentation management with direct experience working with and writing SOP’s.
  • Bi –Lingual (English/Spanish) is a plus.

 

JOB KNOWLEDGE, SKILLS AND ABILITIES:

  • General Knowledge of the food manufacturing process.
  • Must have working knowledge of regulated (FDA) environments as it applies to this position.
  • Capable of performing documentation reviews and investigations.
  • Capable of performing documentation audits.
  • Ability to work with all levels of employees in a productive manner.
  • Excellent communication and interpersonal skills.
  • Ability to, educate, convince, build relationships and influence others.
  • Demonstrated working knowledge of cGMP regulations.
  • Must be able to complete forms and write in a legible manner.
  • Ability to work in a team environment and to follow protocol faithfully.
  • Ability to contribute to Watson’s goals and objectives.
  • Ability to multi-task and bring tasks to completion.
  • Must be computer literate with strong data entry and typing skills in MS Word and MS Excel, MS access is a plus.
  • Able to learn the company’s computer system.
  • Must be able to speak, read and write English fluently.
  • Must be able to perform general math including percentages.
  • Must be highly organized and have good attention to detail.
  • Must have knowledge of HACCP and food allergens.

 

SUPERVISORY RESPONSIBILITIES:

  • None

 

 

 

TRAINING REQUIREMENTS:

  • Sexual Harassment Prevention
  • SOPs as required.
  • On going cGMP training to stay current with all areas required by the company.
  • Any other recommended/required training.

 

PHYSICAL REQUIREMENTS:

  • Light to moderate physical effort required.
  • Continuous mental and visual attention required.
  • Regularly required to sit, stand, reach, bend and walk about the building.
  • May be required to push and or pull carts with wheels containing product being moved about the building.
  • Regularly required to sit, stand, reach, bend, kneel, stoop, crouch, climb/descend stairs and walk about the building.
  • May be required to climb fixed stairs to access loading platforms.
  • Will be required to perform some duties while on the production/warehouse floor with airborne particles and moderate noise.
  • Will be required to travel to our Orange warehouse facility.
  • May be required to travel to our Taylorville, IL facility.
  • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
  • Fine manual motor dexterity required to complete forms and other paperwork.
  • Computer typing is required throughout the day.
  • Lifting up to 25-30 pounds may be required occasionally throughout the week.

 

PERSONAL PROTECTIVE EQUIPMENT:

  • PPE as required/recommended.

 

WORK ENVIRONMENT:

  • Works in an office environment in an assembly facility with air borne particles and moderate noise levels.

 

OTHER:

  • Will be required to perform other duties as requested, directed or assigned.

 


Nearest Major Market: New Haven
Nearest Secondary Market: Hartford