Quality Documentation Expert

2 days ago

Miamisburg, United States Integrated Resources, Inc ( IRI ) Full time

Title: Quality Assurance Expert

Location: Miamisburg, OH

Duration: 5 months+


Support GMP production by performing batch record issuance, review, correction, release, and retention as well as periodic assessments for production lab compliance. Support the site’s maintenance, development and improvement of Quality Systems, such as training, CAPA, deviation, change control, and documentation control. Ensure that all aspects of GMP product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems. Supports the site’s compliance activities through regulatory recordkeeping and reporting.


ESSENTIAL JOB FUNCTIONS:

Process Improvement

Actively participate in the development, implementation, and improvement of Quality Systems.

Routinely support and recommend ongoing process improvements within department, ensuring efficient and value-added processes.

Lead and participate in work with Production, QC, Procurement, Packaging, Maintenance, Customer Service and Marketing to resolve issues and failures with site products and equipment. Work closely with the site departments to implement process changes based on investigation conclusion.

Oversee Trackwise system and aid when necessary to end users to ensure appropriate entries are made and resolution is achieved in a timely manner.

When necessary present various quality system training topics to site personnel.

Identify opportunities for process improvement.

Ensure acceptable product and process consistency

Serve as a primary reviewer of executed GMP batch documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release.

Report all process deviations and/or laboratory OOS results. Investigate QA-pertinent process anomalies.

Assist in writing, reviewing or approving GMP Operating Procedures, Validation Protocols/Reports, Master Production Records, Specifications and other documents for GMP products.

  • Supports the site’s Compliance activities
  • Ensure reports are complete and accurate for HR4You, Trackwise, and Mango and site quality metrics.
  • Ensure appropriate site Quality Assurance personnel are trained as backup for systems role.
  • Facilitate training of other site personnel as required.
  • Follow all safety and quality requirements to complete assigned work.


Job Description:

  • Remains up to date on regulatory requirements, as well as company and corporate quality policies through means such as intercompany meetings, webinars, email services etc.
  • Maintain, clean, and keep safe all work areas and equipment.
  • Maintain personal protective equipment.
  • Complete the volume of work required to meet departmental goals and meet deadlines.
  • Immediately report any situation that could compromise safety or quality.
  • Exemplary attendance and adherence to schedule.
  • Communicate the status of operations and bring critical deviations to the attention of Quality Manager or Site Director in the absence of the Quality Manager.
  • Provide complete and accurate records consistent with quality guidelines.
  • Develop and promote cross functional partnerships with other departments.
  • Ability to serve on committees to improve department, site or company performance. Committees may focus on safety, quality, inventory, output, costs, etc.
  • In compliance with change control procedures, improve processes through application of industry knowledge, experience, and principles.
  • Miscellaneous duties and tasks as assigned by Quality Manager.


BASIC QUALIFICATIONS:

Education and Experience:

Bachelor's degree in Chemistry, Biology, or other Life Science required with 2 or more years GMP related experience in the chemical, specialty chemical and/or pharmaceutical industry

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