Regulatory Compliance Officer
7 days ago
Microbac Laboratories, Inc. is a leading commercial laboratory testing firm that partners with clients worldwide, offering laboratory solutions to the life science, food and nutrition, and environmental industries. We embody a company-wide commitment to exceptional customer experience, which has been refined over nearly 50 years of trusted, analytical and measurement experience.
As a privately held third-party testing company, Microbac operates with a commitment to safety, quality and compliance. Our diverse work portfolio includes broad accreditation offerings and tested insights across the environmental, food and life science markets.
We are seeking a result-focused, dynamic Quality Assurance Specialist who is energized by leading others to solve operational and client services challenges. This position will be housed in our Warrendale, PA location and offers competitive pay, full benefits, and a wonderful opportunity
Key Responsibilities- Ensures effective and current quality systems are in place and adhered to by all staff, resulting in the output of data that is of the highest quality, accurate and defensible
- Serves as the focal point for QA/QC and is responsible for the oversight and/or review of quality control data such as quality records, control charts, calibration records, documentation of corrective actions and other QA/QC data
- Leads, plans, organizes and supports the activities and resources related to implementing and maintaining effective quality systems throughout the laboratory including but not limited to document control, CAPA, internal audits, control charts & trend analysis, approved suppliers and validation of methods, systems & instrumentation
- Has direct access to both local and the highest level of management and has sufficient authority, access to work areas, and organizational freedom to initiate corrective action, to recommend solutions to problems through designated channels and to assure that further work is stopped or controlled until proper resolution of a deficiency has occurred
- Coordinates efforts leading to the acquisition and maintenance of appropriate accreditations, licenses and certificates relevant to the industries that are served by the laboratory
- Conducts internal audits
- Maintains Proficiency Testing Program
- Writes, reviews and revises SOPs and technical reports
- Ensures the laboratory is fully compliant with all relevant regulatory standards
- Serves as the laboratory contact for the Ethics and Data Integrity Program
- Prepares monthly reports both to local divisional management and to the corporate quality team summarizing quality activities at the laboratory
- Hosts and responds to client audits, leads the process to ensure observations are addressed
- Bachelor's degree in a basic or applied science
- Minimum of 4 years of laboratory experience and familiarity with laboratory quality systems
- Familiarity with ISO 17025 and NELAC
- Thorough understanding of ISO 17025 and NELAC
- Knowledge of applicable quality systems and accreditation, licensing and/or certification requirements
- Demonstrated leadership ability.
- Ability to motivate others
- Ability to lead and work with cross-functional teams
- The employee will regularly be exposed to an indoor office setting, as well as a commercial laboratory setting
- Reasonable accommodations will be made for those with disabilities
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