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California Cryobank, Inc. (www.cryobank.com) is one of the largest and most prominent reproductive tissue banks in the world providing sperm banking services and storage of semen, eggs and embryos. Our subsidiary divisions include Family Cord (www.familycord.com), a top-tier umbilical cord blood processing and storage company, and California Cryobank Stem Cell Services, a leading provider of professional services to s....more info
This position will develop, implement and maintain a comprehensive quality assurance/ quality control program in compliance with all standard operating procedures and regulatory/accrediting requirements.
The candidate should be a seasoned QA/QC professional with experience managing multiple locations, including at the Corporate level. The ideal candidate will have the proven ability to successfully tackle unique challenges that require superior interpersonal, problem-solving, and relevant technical skills within an atypical business environment. In addition, experience mapping business processes and using process mapping tools to ensure that all regulatory requirements are met is a plus.
Primary responsibilities include the following: • Oversees Company's Quality Program • Ensures compliance with regulatory/accrediting agency standards and current cGMP • Training, including identifying training needs and assuring quality control of training files • Responsible for ensuring compliance with regulations and standards set forth by federal, state, local, regulatory and accreditation agencies • Ensures that processes comply with all relevant quality standards and regulations; continually reviews all relevant policies/procedures and implements change as necessary • Conducts internal and external audits to document compliance; recommends and implements corrective action when necessary • Acts as the Company's liaison to regulatory/accrediting agencies; develops and coordinates the necessary regulatory responses and agency interaction • Corrective and Preventive Action (CAPA), Nonconformance Report (NCR) and Complaint Management Report (CMR) Systems: • Maintains and coordinates investigations • Assists in resolving quality concerns and issues • Provides constructive and relentless guidance in finding solutions for improvement • Provides ongoing communication of CAPA, NCR and CMR status • Develops process improvement measures to ensure continuous quality and business improvement • Establishes an effective system for ensuring that all production records are in compliance and authorizes cells for release that have met the established criteria • Maintain active role with all regulatory societies (including AATB, FDA, ASRM, etc) • Other duties and projects as required
NOTES:
Local Residents Preferred (No Relo)
Requirements
• Bachelor of Science degree • Experience in managing regulatory affairs and/or quality control; experience with cGMP, FDA and AATB standards desired • Experience with process mapping and business process re-design (preferred, not mandatory) • Experience with FDA auditors (preferred, not mandatory) • Proven ability to manage internal teams • Experience in integrating regulatory requirements into ERP/MIS systems (preferred, not mandatory) • MS Office proficiency - Strong computer skills, including but not limited to, Windows environment (Word, Excel, Access, Power Point – Intermediate to Advanced skills) required. • Excellent written/verbal communication and interpersonal skills • Outstanding problem-solving and organizational skills • Strong attention to detail • Ability to work independently • Ability to concurrently manage multiple projects
Location
Contacts
ASME International Gas Turbine Institute (IGTI)
6525 The Corners Pkwy, Ste. 115
Norcross, Georgia 30092 USA
Tel: +1-404-847-0072
Fax: +1-404-847-0151
General Email Inquiries:igti@asme.org
