Senior Qc Specialist

Certified Group is a leading North American provider of laboratory testing and audit and certification services. The Certified Group of companies includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.), Microconsult Inc. and Micro Quality Labs Inc. The Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, cannabis, nicotine and hemp industries.

We are currently looking for a Senior QC Specialist to join our growing team!

JOB SUMMARY

The Senior QC Specialist will coordinate, and monitor activities of laboratory personnel engaged in sample testing process in relation to quality and apply knowledge of quality assurance and control standards and procedures.

ESSENTIAL RESPONSIBILITIES

• Review of laboratory data.
• Processing deviations, customer complaints, document change requests, root cause analysis and quality agreements.
• Design, revise and maintain the Quality system.
• Develop and instructions for recording, evaluating, and reporting quality data.
• Collaborate with management in maintaining company policies, operating procedures, and goals.
• Participate in activities concerned with development, application, and maintenance of quality standards for internal processes including investigations and CAPAs.
• Keep abreast of regulatory procedures and changes and provide the maintenance necessary to the Quality system.
• Contribute to the development, maintenance, implementation, and coordination of the Quality system to prevent or eliminate issues in new methods or existing ones.
• Suggest and debate alternative methods and procedures in solving problems and testing opportunities.
• Ensure retention of data and preparation of documents for use by self or other company personnel during inquiries and laboratory investigations.
• Participate in external, regulatory, and other audits and assist with internal audits.
• Develop and revise training material and conduct training sessions on quality control activities.
• Ensure QMS maintains completeness and accuracy.
• Review new or modified processes, including documentation, diagrams, and flow charts, to determine if the processes meet and conform to guidelines.
• Provide clerical and administrative support related to a company's documentation system requirements.
• Assist in internal and external audits.
• Assist in compiling regulatory filing documents and in maintaining computerized files to support all documentation systems.
• Work with all employees at the facility.
• Work with internal and external customers.
• Attend professional conferences and seminars for information on techniques, instrumentation, and quality assurance/quality control.
• Other duties as required.

MINIMUM QUALIFICATIONS

• Minimum of a Baccalaureate Degree is required; concentration in Science or Technical writing is preferred.
• A minimum of two (2) years in the cosmetic, pharmaceutical, or related field is required, and two (2) years of regulatory, quality control, or quality assurance experience or equivalent is preferred.
• Laboratory testing experience with wet bench and USP testing at a senior level is preferred.
• A general working knowledge of 21CFR, USP/NF, ICH, cGMP, cGLP and/or ISO standards and guidelines.
• The ability to communicate clearly in English, both orally and in writing, with scientific and non-scientific personnel is required.
• Experience with QualTrax and Microsoft Office is preferred.
• The ability to communicate effectively and solve complex problems.

Benefits:

• Progressive 401k Retirement Savings Plan
• Employer Paid Short- Term and Long-Term Disability, and Life Insurance
• Group Medical
• Tuition Reimbursement
• Flexible Spending Accounts
• Dental
• Paid Holidays and Time Off
• Many positions which qualify for the company bonus program

Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.