Coord QA Document - Milk Specialties Global
Wautoma, WI 54982
About the Job
Summary / Objective: | The QA Document Coordinator has the responsibility for reviewing, maintaining, developing, correcting, all controlled documents and the data within those documents. | ||
Essential Functions: | · Ensure that document control requirements are met for any and all documentation associated with the quality of raw materials, finished goods, and packaging components.
· Administrator of quality control operations for components, packaging, and labels before use in the manufacture of a dietary supplements including:
o Reviewing all receiving records for components, packaging, and labels o Determining whether all components, packaging, and labels conform to specifications established under 111.70 (b) and (d): o Conducting any required material review and making any required disposition decision; o Approving or rejecting any treatment and in-process adjustments of components, packaging, or labels to make them suitable for use in the manufacture of a dietary supplement; and o Approving, and releasing from quarantine, all components, packaging, and labels before they are used.
· Perform batch record review for intermediate and finished products. Be able to identify deficiencies and facilitate resolution prior to QA release.
· Assist with the development, writing, approval, implementation and training of SOPs. Ensure that controlled copies of SOPS are current and available to employees.
· Perform QA release on these materials in LIMS when acceptance criteria are met.
· Perform System 21 inventory status functions as needed
· Develop knowledge and skills necessary to provide assistance for general QA work, including finished product problem investigations and customer complaint reviews.
· Develop and issue Certificates of Analysis for finished products.
· Ensure that all aspects of GMPs are being met and that products are manufactured according to GMP guidelines.
· Provide or coordinate data entry of quality and analytical information.
· Work with production personnel to ensure that batch records and other associated documentation is complete and accurate.
OTHER RESPONSIBILITIES: · Provide assistance as needed to ensure that information is conveyed in a timely manner.
· Complete special projects as assigned in an accurate and timely manner, reporting all data and observations.
· Be instrumental in streamlining the QA process. Give input on ways to improve the QA process within GMP parameters. Look for ways to improve efficiency
· Be ready to step into any situation to help problem solve and to provide solutions.
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Supervisory Responsibilities: | None | ||
Work Enviornment: | QA Lab - Exposure to both laboratory environment and manufacturing plant. Subject to noise, odor, dust and discharge from production process. Exposure to various laboratory chemicals. | ||
Physical Demands: | Light Heavy Work - Lifting 50 pounds maximum with frequent lifting and/or carrying of objects weighing up to 30 pounds.. | ||
Travel: | None | ||
Education: | Required: | High School Degree or Equivalent |
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Preferred: | Associates Degree or Equivalent | Click here to enter text. | |
Experience/Qualifications: | Required: | Excellent knowledge of testing procedures. Strong knowledge of computer software applications including windows based programs and System 21. Excellent analytical and organizational skills. Previous experience in a GMP environment is a beneficial. | |
Preferred: | Click here to enter text. | ||
Other Duties: | 1. Take personal responsibility to engage in plant and food safety practices to prevent hazards that cause foodborne illness or injury and provide a clean, safe work environment and quality products. 2. Report actual or potential food safety concerns to management in a timely fashion. 3. Have an awareness of food safety metrics and SQF Code as it relates to employee’s role. 4. Actively participate in building a food safety and quality culture 5. Qualified and trained individual will provide as a back-up in the event of an absence of another employees. 6. Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. 7. Perform special projects and other responsibilities as needed. 8. Duties, responsibilities and activities may change at any time with or without notice. |
The above statements reflect the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.
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