QA/QC Manager

The QA/QC Manager is responsible for managing routine quality assurance and quality control needs associated with manufacturing, testing of APIs, finished drug products, quality systems maintenance, improvement initiatives, and compliance to GMP quality and regulatory standards. Serves as first responder for manufacturing and packaging deviations. Works closely with the manufacturing team to assure the appropriate immediate actions and corrective actions are taken for deviations. Acts as a resource to production regarding quality issues.

Education:
• Minimum of an Associate of Science degree
• Bachelors preferred
Required Experience:
• Quality professional with 2-5 years of hands-on experience with document control management in the pharmaceutical industry with at least 2 years supervisory capacity.
Training/Licenses/Certificates:
• Certificates of Training in subject area of cGMP, ISO, or Certification of Quality disciplines
• TQM are preferred
• Six sigma preferred
Required Duties/Responsibilities:
• Owns and maintains the Quality Management System; Quality Management Reviews; Manage Quality Investigations; Reviews adequacy of root cause determination, corrective actions, preventative actions and effectiveness; Reviews quality outputs, change control, validation, deviations, etc. and qualification for accuracy and completeness
• Pharmaceutical responsibilities; Oversees movement of controlled substance within their designated facility to and from secured location
• Review gap analysis of systems
• Clinical experience is preferred
• Working with CROs
• Familiar with cGMP and 21CFR210/211 and other applicable regulations
• KPIs; Coordinates the preparation revision, review, and approval of SOPs and other GMP documents; Organizes and ensures accurate and reliable filing systems both electronically and paper based for GMP documents
• Commissioning new clean rooms
• Quality Events
o Change Controls, CAPA’s, Risk Assessments and Supplier Corrective Actions
o NC’s
• Facilitating audits
o ISO, GMP, CDPH, City of Ox, DEA, Supplier and Internal
• Reviews laboratory data and reports and audits records for compliance
• Identifies, evaluates, and implements electronic document processing and archiving systems
• Generates metrics as needed
• Oversight of facility and product regulatory affairs
Knowledge, Skills and Abilities:
• eQMS Re-Validation
• Security Systems
• Excellent verbal and written communication skills
• Proficiency in MS Office Suite; Knowledge in O365 and SharePoint
• Demonstrates confidentiality in execution of all responsibilities
• Must be a self-starter and have a positive and flexible attitude
• High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines
• Excellent presentation and facilitation skills
• A demonstrated commitment to high professional ethical standards and a diverse workplace
• Ability to adapt to a fast-paced business and work environment while managing multiple priorities

WORK ENVIRONMENT/OTHER INFORMATION
• Office environment and manufacturing environment
• Requires intermittent physical effort
• Frequent computer use at workstation
• Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands
• Occasional public contact requiring appropriate business apparel
• Occasional travel