Quality Specialist

4 weeks ago

Grove City, United States Health Care Logistics, Inc. Full time
Job DescriptionJob Description

Position Title: Quality Specialist

Department: Quality

Reports To: Quality Engineer

Workdays: Monday - Friday

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

Join our team and have a successful growing career with Health Care Logistics

We have a casual and fun work environment with the necessary tools and resources to help you build success and growth within the company. HCL offers competitive compensation, including a great benefits package, as well as opportunities for professional growth and development. If you are a driven individual with a passion for quality, we would love to hear from you Excellent work life balance - never take work home with you

Primary Function

The position will inspect, sample, and test HCL products, packaging, and materials to ensure compliance with internal quality standards and external quality standards imposed by state and federal regulations. The position will have independent discretion and authority to stop orders from leaving the facility or from being placed into stock if they do not meet quality standards until such time as any issues are resolved. The position will lead and coordinate cross-functional teams to resolve any quality issues identified. The position has independent discretion and authority to initiate complaint investigations regarding quality control issues. Inspect, sample, and test products, packaging, and materials to ensure compliance with internal quality standards and external quality standards imposed by state and federal regulations.

  • Independent discretion and authority to stop orders from leaving the facility or being placed into stock if they do not meet quality standards and until such issues are resolved.
  • Independent discretion and authority to contact and coordinate with the purchasing department and send notices of non-conformance and/or complaints to manufacturers.
  • Independent discretion and authority to initiate complaint investigations.
  • Train staff in Good Documentation Practices (GDP), Good Manufacturing Practices (cGMP), and current procedures. The position will also assist in the development of procedures and training programs as needed.
  • Maintain records and files.
  • Document and escalate quality issues as they arise.
  • Conduct periodic training for staff.
  • Writing, reviewing, and revising Quality Control documents, including but not limited to protocols, validations, method qualifications, standard operating procedures (SOPs), writing instructions (WIs) and technical reports.
  • Maintain records and files.
  • Lead cross functional documentation projects as requested and under the direction of the VP, Quality & Regulatory Affairs
  • Write clearly and concisely to meet the needs of the target audience.
  • Responsible for leading required training classes for quality and regulatory issues
  • Ensure compliance with corporate (SOPs) and regulatory requirements (e.g., GDP and cGMP)
  • Conduct quarterly training for staff.
  • All other duties as assigned.

Requirements

  • BS/BA in Science degree preferred with 5 years of experience in a cGMP setting or 10 years of experience in a cGMP setting.
  • Knowledge of current U.S. and international regulations pertaining to documentation
  • Previous QA training is a plus.
  • Excellent presentation, organizational and communication skills.
  • Multitasking ability
  • Attention to detail.
  • Good interpersonal skills
  • Experience in medical device or pharmaceutical industry.
  • Familiarity with CFR 820 and/or ISO 13485 is a plus.
  • Experience working in a self-driven, performance/results oriented, fast paced matrixed environment.
  • Excellent critical and analytical skills

Benefits Program

Our benefits are incredible

We offer a benefits package that includes:

  • 6 Paid Holidays
  • Full time benefits 1stof the month after 60 days of employment.
  • Medical Insurance: We offer two medical plan options with low deductibles. Save more on premiums by qualifying for wellness rates
  • 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 (Prorated hours are given after 1stof the month after 60 days of employment)
  • 401(k) Retirement including 4% company match
  • Company Paid Life Insurance
  • Voluntary Life Insurance available for you, your spouse, and your children
  • Company Paid Short and Long-Term Disability Insurances
  • Extensive Bereavement Leave Policy
  • Employee Assistance Programs
  • Rainy Day Savings Program

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