GMP Quality Assurance Senior Specialist

Cambridge Isotope Separation (CIS) has an outstanding opportunity for a GMP QA Senior Specialist based in our Xenia, Ohio 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.

Primary responsibility of the GMP Quality Assurance Senior Specialist is to work as a team member to uphold compliance and maintenance of the Company’s cGMP (Current Good Manufacturing Practices) and Quality systems to in-house and/or external specifications, standards, and regulations. Helps to establish quality standards for products and processes and suggest modifications to prevent defects in components or final products. Works closely with cross-functional teams to identify and mitigate quality risks. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Work is performed primarily in an administrative office environment.

Responsibilities:

• Oversight and maintenance of various Quality Systems (e.g. CAPA, Deviation, Supplier Management, Customer Complaints, biennial review, internal/external auditing, etc.)
• Conduct root cause analysis for defects, non-conformities, or other quality failures and report approval
• Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary
• Act as an administrator of CIS’s electronic Quality Management System (eQMS) • Perform document writing/revisions, document/data review/approval, change control coordination/approval, continuous improvements, and other duties as needed
• Design/implement quality assurance protocols, procedures, and methods for evaluating the performance of processes, equipment, and finished products
• Author/review various reports (e.g. annual product reviews, annual deviation/CAPA/EM reports)
• Lead and/or actively participate in internal/external/supplier audits, risk management programs, and project meetings, as needed
• Act as Team Leader in the absence of Team Leader/Supervisor/Manager to subordinate employees
• Perform other duties as needed including, but no limited to:
• Raw material documentation review and release
• Batch record review and release of finished products
• Perform room/line clearances
• Revision and creation of documents, including SOP’s and forms o Label review and final inspection
• Create batch records, logbooks and controlled forms
• Initiation, tracking, review, final distribution, and reconciliation of GMP documents
• Review of facility/utility monitoring data

Requirements

• Bachelor’s degree in chemistry/sciences or quality assurance/management; equivalent applicable industry experience may be substituted for the degree requirement
• Minimum of 8 years of experience in a cGMP Quality, regulatory, and/or chemical manufacturing environment, with increasing responsibilities and independence
• Experience with GMP Quality Assurance and knowledge and experience with ICH Q7A is preferred
• Applied knowledge of GMP principles across quality disciplines, including but not limited to: Batch Record Review, Change Control, Training, Investigations, CAPA, Supplier Qualification, Process Validation/Qualification
• Competencies: Technical expertise, Problem-solving skills, Leadership skills
• Ability to identify and seek needed information/Research skills
• Excellent interpersonal, verbal and written communication skills
• Attention to detail, organizational skills, ability to multitask and follow tasks through to completion. 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.

CIL is an EEO/Affirmative Action employer.

Learn more about us on our website: www.isotope.com

About Us:

Cambridge Isotope Laboratories, Inc. (CIL) is the world’s leading producer of st