Quality Specialist

Health Care Logistics•Grove City, OH

12d

About The Position

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 Functi on 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 regulatio ns. 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 resol ved.Independent discretion and authority to contact and coordinate with the purchasing department and send notices of non-conformance and/or complaints to manufactur ers.Independent discretion and authority to initiate complaint investigati ons.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 nee ded.Maintain records and fi les.Document and escalate quality issues as they ar ise.Conduct periodic training for st aff.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 repo rts.Maintain records and fi les.Lead cross functional documentation projects as requested and under the direction of the VP, Quality & Regulatory Aff airsWrite clearly and concisely to meet the needs of the target audie nce.Responsible for leading required training classes for quality and regulatory is suesEnsure compliance with corporate (SOPs) and regulatory requirements (e.g., GDP and c GMP)Conduct quarterly training for st aff.All other duties as assig ned.

Requirements

BS/BA in Science degree preferred with 5 years of experience in a cGMP setting or 10 years of experience in a cGMP se tting.
Knowledge of current U.S. and international regulations pertaining to documen tation
Excellent presentation, organizational and communication s kills.
Multitasking a bility
Attention to d etail.
Good interpersonal skills
Experience in medical device or pharmaceutical ind ustry.
Experience working in a self-driven, performance/results oriented, fast paced matrixed enviro nment.
Excellent critical and analytical skills

Nice To Haves

Previous QA training is a plus.
Familiarity with CFR 820 and/or ISO 13485 is a plus.

Responsibilities

Inspect, sample, and test products, packaging, and materials to ensure compliance with internal quality standards and external quality standards imposed by state and federal regulatio ns.
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 resol ved.
Independent discretion and authority to contact and coordinate with the purchasing department and send notices of non-conformance and/or complaints to manufactur ers.
Independent discretion and authority to initiate complaint investigati ons.
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 nee ded.
Maintain records and fi les.
Document and escalate quality issues as they ar ise.
Conduct periodic training for st aff.
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 repo rts.
Maintain records and fi les.
Lead cross functional documentation projects as requested and under the direction of the VP, Quality & Regulatory Aff airs
Write clearly and concisely to meet the needs of the target audie nce.
Responsible for leading required training classes for quality and regulatory is sues
Ensure compliance with corporate (SOPs) and regulatory requirements (e.g., GDP and c GMP)
Conduct quarterly training for st aff.
All other duties as assig ned.

Benefits

6 Pai d Holidays
Full time benefits 1stof the month after 60 days of e mployment.
Medical Insurance: We offer two medical plan options with low deductibles. Save more on premiums by qualifying for welln ess rates!
Dental Insurance
Prescription Drug Program with low copays
VSP Vision Insurance
Flexible Spendin g 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 e mployment)
401(k) Retirement including 4% com pany match
Company Paid Life Insurance
Voluntary Life Insurance available for you, your spouse, and you r children
Company Paid Short and Long-Term Disability Insurances
Extensive Bereavement Le ave Policy
Employee Assistanc e Programs
Rainy Day Savin gs Program