Cambridge Isotope Separations (CIS) has an outstanding opportunity for a Quality Assurance Senior Specialist based onsite in our Xenia, OH location. CIS is the world leader in the separation of 13C and 18O and is a subsidiary of Cambridge Isotope Laboratories (CIL) in Massachusetts, the world’s leading producer of stable isotopes and stable isotope-labeled compounds. CIL separates both 13C and 18O at its Xenia, Ohio, facility and has the world’s largest production capacity for both 13C and 18O. CIL also has the only large capacity nongovernmental D2O (Deuterium Oxide) enrichment columns in the world located at its CIS facility.

Summary

The Quality Assurance Senior Specialist will administer and indorse quality standards to ensure products, services, and processes consistently meet intended purpose and stakeholder expectations through individual and team contributions. The individual supports the maintenance, integration, and improvement of the company’s quality management systems (QMS), encompassing cGMP and ISO 9001 operations.

Responsibilities

Oversee and maintain assigned processes within the QMS (e.g. deviations, CAPA, suppliers, etc.).
Conduct root cause analysis for investigations to identify trends, potential risks, and opportunities.
Assess risk, product, and process assessments along with the potential impact to develop appropriate corrective actions or mitigation activities.
Determine and complete appropriate effectiveness checks.
Review quality trends, production data, and recurring issues to recommend and/or implement improvements to processes, procedures, and controls.
Write, review, and revise SOPs, forms, specifications, protocols, reports, and other controlled documents.
Support qualification and validation activities, where applicable, through review of protocols, reports, acceptance criteria, and supporting documentation.
Prepare or review annual product reviews where applicable, QMS performance summaries, and quality data for management review.
Lead or participate in internal, customer, supplier, and certification audits; support regulatory inspections and track assigned follow-up actions.
Review batch or production records, test results, certificates of analysis, and specifications. Perform material and product release or disposition under applicable GMP or ISO 9001 QMS procedures, product specifications, and customer requirements when trained and formally authorized.
Provide practical quality guidance, training, mentor colleagues, and lead assigned improvement projects.
Support integration of GMP and ISO 9001 QMS processes by harmonizing procedures, forms, workflows, and training while retaining applicable product, regulatory, and customer controls.
Act as lead or designee in the absence of quality manager or quality assistant manager.
Perform other related duties as assigned.

Requirements

Bachelor’s degree in chemistry/sciences, quality assurance/management, or equivalent.
10+ years of experience with quality systems, GMP regulatory compliance, methods and procedures preferably in a pharmaceutical environment. Knowledge of GMP guidelines and regulations.
Experience with investigations, CAPA, change control, document control, batch record review, risk assessment, supplier qualification, and validation or qualification activities.
Ability to assess technical information, identify quality risks, make sound recommendations, and recognize when escalation is needed.
Strong technical writing, problem-solving, organizational, and communication skills; attention to detail and ability to manage competing priorities through completion.
Applied knowledge of cGMP principles, API expectations, regulatory filing requirements preferred.
Work independently and in a team environment.

Benefits

CIL and CIS offer a competitive salary and comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible.

Cambridge Isotope Laboratories is an Equal Opportunity Employer.

Learn more about this Employer on their Career Site