QA Document Control Specialist

JOB SUMMARY

Under general supervision the QA Document Control Specialist is responsible for the control review approval retention and retrieval of quality system documentation including batch history records (BHRs) generated during daily operations at PelFreez. The role ensures documentation meets internal quality standards and applicable regulatory and ISO requirements and supports material and product release activities.

ESSENTIAL DUTIES FUNCTIONS AND RESPONSIBILITIES

• Supply and Material Procurement (QualityControlled):
  • Assist the Quality Systems Manager with approved supplier documentation qualification records and vendorrelated quality activities in accordance with established procedures.
• Equipment:
  • File and organize equipment calibration documentation
• Technical:
  • Develop and maintain a controlled filing and indexing strategy to ensure timely accurate secure and traceable retrieval of quality system documentation.
  • Assist the QS Specialist with investigations of process non-conformances.
• Change Initiatives:
  • Initiate and support minor procedural changes within Quality Systems and Production in accordance with approved change control procedures.
• Quality Systems Management:
  • Participate in internal audits investigate customer complaints and support investigation process for non-conformances and CAPAs.
  • Respond to customer requests for information such as certificates of analysis (COAs) and supplier evaluations etc.
• Records Reviews and Approvals:
  • Review all batch history records (BHRs) for completeness accuracy traceability and compliance with approved procedures and regulatory requirements.
  • Follow-up with internal stakeholders when errors or corrections need to be made on documentation.
  • Release all materials for use from incoming inspections
  • Release finished good and WIP batches for use or shipment after BHR review.
  • Review and Release all Raw Materials received
• Professional Development:
  • Update job knowledge by participating in educational opportunities and maintaining personal networks.
• Quality System Promotion:
  • Understand and promote the quality system to support the companys goal of continual improvement.
  • Comply with PelFreez policies and applicable requirements of the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) ISO standards Occupational Safety and Health Administration (OSHA) animal welfare requirements Good Manufacturing Practices (GMP) and all applicable quality and safety procedures.
• Exhibit exemplary attendance and punctuality.
• Perform other duties as assigned.

Based on the essential duties listed above this position is considered safety-sensitive and therefore all work must be performed following quality standards and established safety procedures.

EDUCATION & RELATED EXPERIENCE

• High school diploma or GED required with five (5) or more years of experience in Quality Assurance or document control within an ISO FDA or USDAregulated manufacturing environment.
• Experience with quality principles and the interpretation and application of quality standards of industry regulations (e.g. ISO 9001) is preferred.

KNOWLEDGE SKILLS AND ABILITIES

• Strong understanding of quality assurance document control records management and regulatory compliance principles.
• Familiarity with industry standards and regulations such as ISO 9001 good manufacturing principles (GMP) and other relevant guidelines.
• Knowledge and understanding of safety procedures and industry regulations and guidelines required by the Occupational Safety and Health Administration (OSHA) United States Department of Agriculture (USDA) and Food Safety and Inspection Service (FSIS).
• Familiarity with biological production a plus.
• Intermediate experience in utilizing Microsoft Office Suite.
• Meticulous attention to detail to ensure accuracy in testing and reporting.
• An individual displays reliability and responsibility has an excellent attendance record and regularly fulfills work obligations.
• The ability to calculate figures and amounts such as percentages area and volume fractions ratios and proportions and apply statistical analysis.

SUPERVISORY RESPONSIBILITIES AND INTERACTIONS WITH OTHERS

The QA Document Control Specialist has no supervisory responsibilities. However the role will be expected to frequently interact with co-workers management and the general public.

PHYSICAL REQUIREMENTS

WORKING CONDITIONS

Work is performed in an indoor environment but exposure to fluctuations in temperature may be required. Work will be conducted in areas where biological products are collected and tested and the position may face exposure to human/animal blood inorganic solvents hazardous chemicals biohazards and other related materials. Work is conducted in the ISO classified areas where standard operating procedures and OSHA requirements must be followed. The noise level in the work environment is usually moderate.

This job description is only a summary of the typical functions of the job not an exhaustive or comprehensive list of all possible job responsibilities tasks and duties. The responsibilities tasks and duties may differ from those outlined in the job description and other duties as assigned may be required. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion national origin age sex sexual orientation gender identity disability veteran status genetic information or any other status protected under applicable local state or federal nondiscrimination laws.

This document does not create an employment contract. Employees are employed on an at-will basis and may be terminated at any time. Consistent with all federal and state disability laws Pel-Freez will provide reasonable accommodation when requested by a qualified applicant or employee with a disability unless such accommodation would cause a direct threat to this individual or others in the workplace and the threat cannot be eliminated by reasonable accommodation or cause undue hardship to the organization Pel-Freez provides equal employment opportunities to all applicants.

Required Experience:

IC