Quality Assurance Manager

Kittanning, PA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Full-time

Description

The Quality Assurance Manager leads the labs Quality Management System (QMS) ensuring data accuracy and regulatory compliance by developing policies conducting audits managing accreditations and overseeing training while fostering a culture of quality in which precision integrity and innovation are essential. This role partners closely with Laboratory Operations teams to establish uphold and improve quality standards across all products services and operations in support of Metiris mission to contribute to environmental sustainability.

Quality System Management

Develop implement and maintain the QMS including the Quality Manual SOPs and Chemical Hygiene Plans ensuring adherence to local state and federal standards.
Oversee data review statistical process control and final report sign-off for external customers ensuring data validity.

Audit & Compliance

Schedule and perform internal audits coordinate external audits (client regulatory third party) and manage responses to deficiencies.
Actively engage with regulatory bodies/associations and industry alerts to stay up-to-date on new rules (like FDA ISO GMP) to ensure continuous adaptation and audit readiness.

Training & Staff Development

Lead manage and mentor other members of the Quality Assurance team.
Develop and deliver QA training monitor staff training records and ensure all personnel understand quality protocols and ethical standards.

Accreditation

Manage accreditation applications renewals and interactions with accrediting bodies.
Act as the primary contact for quality matters with management regulatory agencies clients and accrediting bodies.

Continuous Improvement

Lead root cause analysis investigations and implement corrective/preventive action (CAPA) processes.
Identify quality trends and promote efficiency/accuracy improvements.
Communicate with cross-functional teams regarding quality standards across all products services and operations to promote precision integrity and innovation.
Perform all other duties as assigned.

Requirements

Education:

Bachelors degree in a science engineering or business-related field; or equivalent (high school diploma/GED combined with 4 years of progressive experience in related field).

Experience/Qualifications:

5 years of progressive experience in a quality assurance role required; 2 years in a QA leadership role overseeing compliance and accreditation preferred.
Working knowledge of environmental regulations and accreditation standards (e.g. ISO 9001 FDA GMP).
Understanding of LIMS framework quality control procedures/principles and managing QMS functions within the laboratory system.

License/Certification:

Valid drivers license and an excellent driving record for the past three years.

Knowledge/Skills/Abilities:

High proficiency in Microsoft Office (Excel Word Outlook).
Exceptional accuracy organization and attention to detail.
Strong problem-solving and analytical skills with the ability to identify issues and propose logical solutions.
Ability to work both independently and collaboratively in a team environment to identify and resolve problems gather and analyze information and meet time-sensitive deadlines.
Professional communication skills including: reading and interpreting written information; writing clearly and legibly such as when preparing forms/logs/reports; listening to understand directives feedback or complex issues; and speaking clearly and persuasively to share information ask follow-up questions or manage difficult conversations.
Demonstrated leadership skills to manage and mentor staff and to interact with management accreditation bodies regulatory agencies and clients as a primary contact for quality matters.
Ability to safely operate a motor vehicle and navigate routine hazards of the road for regular travel between worksites and client locations.

Work Environment:

Laboratory environment with exposure to chemicals and testing equipment.
Requires adherence to safety protocols including the use of personal protective equipment (PPE).

Physical Demands:

Primarily sitting for extended periods with occasional standing walking short distances stooping crouching reaching and lifting/carrying up to 10lbs.
Repetitive use of hands/fingers and fine motor skills for typing writing operating keyboards and using phones.
Close visual acuity to view computer monitors and read/prepare data.

Travel Requirements:

Requires 20% travel between worksites or customer locations within the region which includes Kittanning PA Pottsville PA and Cleveland OH.
Fuel and per diem included for business travel.

Equal Employment Opportunity:

Metiri Analytical Group Inc. is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination based on race color sex religion age national origin disability genetics veteran status sexual orientation gender identity or expression or any other characteristic protected by federal state or local laws.

Required Experience:

Manager

Full-timeDescriptionThe Quality Assurance Manager leads the labs Quality Management System (QMS) ensuring data accuracy and regulatory compliance by developing policies conducting audits managing accreditations and overseeing training while fostering a culture of quality in which precision integrity...