QS - Quality Supervisor

Certified Group is committed to delivering expert solutions and quality testing our customers can feel confident in – on time, every time – so the world can trust in what it consumes. As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries. 

We have embarked on an important journey to unify and strengthen our culture by living these core values: Start with the Customer, Drive to Deliver, Commit to Safety and Quality, and Believe in the Team — including believing in you.

We are currently looking for a Quality Supervisor to join our growing team!

This key role will supervise personnel and processes within the Quality Department. Including but not limited to developing, applying, and maintaining quality standards for all processes, associated documents, methods, and procedures. All must comply with cGMPs, ICH, USP/NF, and the appropriate CFR/FDA regulations and guidelines.

ESSENTIAL RESPONSIBILITIES

• Supervise all activities related to the QMS and ensure staff compliance to each process.

• Maintain compliance with regulatory requirements, cGMP guidelines, and acceptable scientific practice.

• Supervise and improve tracking and filing of document control systems.

• Participate in external, regulatory, and other audits. Coordinate internal audits based on quality assurance criteria.

• Supervise training program including materials and training sessions on quality activities.

• Act with impartiality and work in accordance with the laboratories and management.

• Act in a way to not be influenced by perspectives, value judgments, community bias, or personal interests that could compromise impartiality.

• Communicate possible impartiality risks to management.

• Interpret and implement quality standards in all departments to ensure applicable regulations and guidelines are met for all processes including test methods.

• Review quality standards, study existing policies and procedures, and evaluate effectiveness of quality program.

• Develop initial and subsequent modifications of quality documentation to delineate areas of responsibility, personnel requirements, and operational procedures within program, according to and consistent with company goals and policies. Write and revise quality assurance policies and procedures.

• Develop forms and instructions for recording, evaluating, and reporting quality data.

• Supervise SOP review schedule for revision of procedures, specifications, and forms.

• Assist management team in formulating and establishing organizational policies and operating procedures for company.

• Supervise and participate in processing change control, deviations, customer complaints, risk analysis/assessments, root cause analysis and CAPA’s.

• Keep abreast of regulatory procedures and changes.

• Compile all material required for submissions, license renewals, and annual registrations and management review.

• Assist in ensuring the quality program is maintained in a manner to prevent or eliminate issues in new methods and/or existing ones.

• Suggest and debate alternative methods and procedures in solving problems and testing opportunities.

• Supervise retention and destruction of data, preparation of documents for use by self or other company personnel during inquiries and laboratory investigations.

• Recommend response to complaints, considering test reports and records, legal standards, and complaint validity.

• Work with all employees at the facility.

• Work with external departments, such as customer quality assurance and control, customer management, concerning observations and external audits.

• Interact with external departments and professional networks in such a way to not allow the possibility of external issues, pressures, and bias to compromise the company’s commitment to impartiality and laboratory operations and quality functions.

• Attend professional conferences and seminars for information on software, laboratory techniques, instrumentation, and quality assurance/quality control.

MINIMUM QUALIFICATIONS

• Minimum of a Baccalaureate Degree is required; concentration in Quality Systems, Biological or Chemical Science is desirable.

• A minimum of five (5) years of regulatory, quality control, or quality assurance experience or equivalent is required.

• Five (5) years of management experience is preferred; or (2) two years of management or supervisory experience at Certified Group is desirable.

• A minimum of five (5) years in the cosmetic, pharmaceutical, or related field is required.

• A general working knowledge of GxP, CFR, FDA, USP/NF, ICH, cGMP, cGLP, ISO standards and guidelines.

• Ability to access, input, and retrieve information utilizing various software systems.

• Able to maintain confidentiality and adhere to established laboratory safety practices.

• Strong communication skills clearly in English, both orally and in writing, with scientific and non-scientific personnel is required.

• Ability to work efficiently and effectively in a productive manner, as well as ability to shift prioritization of tasks in a fast-paced environment.

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.