Job Openings
OVERALL SUMMARY OF POSITION:
Ensures the development, implementation, and maintenance of quality control systems. Interacts with outside contacts, customers, partners, subordinates, and peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others and influence management and peers at various levels.
Defines problems, establishes facts, and draws conclusions based on the information obtained. Interprets an extensive variety of technical issues in order to achieve the goals of the department and the company.
ESSENTIAL DUTIES:
§ Reports to VP of Quality on laboratory issues. Interacts with others to provide input into those functions.
§ Ensures chemical testing and microbiological testing are completed on schedule and in compliance with cGMP’s and other regulatory requirements.
§ Ensures GMP and GLP compliance through implementation of programs and quality systems in Quality Control.
§ Cooperates with other management personnel in formulating and establishing company policies, operating procedures, and goals for the QC department.
§ Reviews technical problems and procedures and recommends solutions to problems or changes in procedures.
§ Quality oversight of all QC processes.
§ Ensures compliant and timely testing and release of XOMA products.
§ Oversees technical quality reports for submission to regulatory authorities.
§ Responsible for interviewing, hiring, and training employees; planning, assigning and directing Quality Control department work functions; appraising performance; rewarding and disciplining QC employees.
OTHER DUTIES:
§ Participates in compliance inspections by external companies and regulatory agencies.
§ Reviews technical publications, articles, and abstracts to stay current with technical developments in industry.
SUPERVISORY RESPONSIBILITIES:
§ Supervises the management within the QC Department. Is responsible for the overall direction, coordination, and evaluation of the QC department.
§ Carries out department responsibilities in accordance with the organization’s policies and applicable laws.
QUALIFICATIONS/REQUIREMENTS
Education and/or experience:
§ BA/BS, MA/MS degree in Biochemistry, Chemistry, Pharmacy, or related science with a minimum of 10 years experience in a biotechnology environment; or equivalent combination of education and experience.
§ Experience with bioprocess technology and compliance.
Special skills/knowledge:
§ Thorough knowledge of quality systems for laboratories, US and EU GxP, and associated regulations.
§ Effective communication skills: verbal, written, and interpersonal skills.
§ Project Management skills.
