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Quality Control Analyst

2 months ago

Grove City, Ohio, United States Health Care Logistics, Inc. Full time
Job Overview

Position Title: Quality Specialist

Department: Quality Assurance

Reports To: Quality Engineer

Workdays: Monday - Friday

Work Schedule: 8:00 am - 4:30 pm

Become a part of our dynamic team at Health Care Logistics, Inc. and advance your career in a supportive environment.

We foster a relaxed and enjoyable workplace, equipped with the essential tools and resources to facilitate your success and growth within the organization. HCL provides competitive remuneration, an attractive benefits package, and opportunities for professional advancement. If you possess a strong commitment to quality, we are eager to connect with you. Enjoy a healthy work-life balance - leave work at work.

Key Responsibilities

The Quality Specialist will conduct inspections, sampling, and testing of HCL products, packaging, and materials to ensure adherence to both internal quality benchmarks and external regulatory standards. This role carries the authority to halt orders from dispatch or stock placement if they fail to meet quality criteria until issues are rectified. The position will also lead and coordinate cross-functional teams to address any identified quality concerns and initiate investigations into quality control complaints.

  • Exercise independent judgment to prevent orders from leaving the facility or being stocked if they do not comply with quality standards until resolution.
  • Coordinate with the purchasing department and issue notifications of non-conformance or complaints to manufacturers.
  • Initiate investigations into quality-related complaints.
  • Train personnel in Good Documentation Practices (GDP), Good Manufacturing Practices (cGMP), and current operational procedures, while assisting in the development of necessary training programs.
  • Maintain comprehensive records and documentation.
  • Document and escalate quality issues as they arise.
  • Conduct regular training sessions for staff.
  • Draft, review, and revise Quality Control documentation, including protocols, validations, method qualifications, standard operating procedures (SOPs), and technical reports.
  • Lead cross-functional documentation initiatives as directed by the VP of Quality & Regulatory Affairs.
  • Communicate clearly and concisely to meet the needs of various audiences.
  • Facilitate required training sessions on quality and regulatory matters.
  • Ensure compliance with corporate SOPs and regulatory standards (e.g., GDP and cGMP).
  • Conduct quarterly training for staff.
  • Perform other duties as assigned.
Qualifications
  • Bachelor's degree in a Science-related field preferred, with a minimum of 5 years of experience in a cGMP environment or 10 years of relevant experience.
  • Familiarity with current U.S. and international regulations regarding documentation.
  • Previous quality assurance training is advantageous.
  • Strong presentation, organizational, and communication skills.
  • Ability to multitask effectively.
  • Meticulous attention to detail.
  • Strong interpersonal skills.
  • Experience in the medical device or pharmaceutical sector.
  • Knowledge of CFR 820 and/or ISO 13485 is a plus.
  • Experience in a self-driven, performance-oriented, fast-paced matrix environment.
  • Excellent critical thinking and analytical skills.
Benefits

We offer an exceptional benefits package that includes:

  • 6 Paid Holidays
  • Full-time benefits starting on the 1st of the month after 60 days of employment.
  • Medical Insurance with two plan options featuring low deductibles.
  • Dental Insurance
  • Prescription Drug Program with low copays
  • VSP Vision Insurance
  • Flexible Spending Accounts
  • Paid time off - 7 vacation days and 8 personal days starting at your first full year of service.
  • 401(k) Retirement plan with a 4% company match.
  • Company Paid Life Insurance
  • Voluntary Life Insurance options for you and your family.
  • Company Paid Short and Long-Term Disability Insurance
  • Comprehensive Bereavement Leave Policy
  • Employee Assistance Programs
  • Rainy Day Savings Program