Sr. Manager, Quality Assurance Auditor Ambit Biosciences
THIS JOB HAS EXPIRED Description:
The Q.A. Auditor will work with the Quality Assurance team to develop and fulfill an efficient and effective plan to maximize the value of Ambit?s products. The Q.A. Auditor is expected to provide oversight of the ongoing development of AC220 and other compounds by conducting regular audits of vendors and clinical sites.
Essential Job Functions:
?Plan, prepare and conduct GXP (including GMP, GLP, and GCP) audits. This includes planning, execution, and writing of reports and follow-up
?Write and maintain audit reports, audit schedules/plans, and other documents as required
?Audit types include vendor qualifications, in-process quality audits, quality systems audits, Pre-Approval Inspection readiness (PAI) audits, and clinical investigator site audits
?Manage global audit plans
?Assist in the execution of internal audit program ensuring site compliance with all appropriate regulations and standards
?Assist with audits of internal documents, such as Clinical Study Reports and other Technical Reports, as needed
?Participate in regulatory inspections and other audits, as appropriate
EDUCATION:Bachelors Degree in scientific discipline or related field.
EXPERIENCE:Minimum of five (5) years of Drug Development experience, including quality assurance and compliance experiences in GCP/cGMP/GLP/Pharmaceutical environment or equivalent with pharmaceutical sponsored clinical research.
Minimum of two (2) years of GXP auditing experience.
COMPETENCIES AND SKILLS:?Extensive knowledge of GCPs/cGMP regulations, ICH Guidelines, for clinical and CMC
?Excellent communication, organizational, interpersonal and computer skills
?Ability to interact with multiple regulatory agencies
?Collaborative team player that can establish and maintain effective working relationships with other departments, the FDA, and outside vendors
?Excellent interpersonal skills with knowledge of negotiations, influencing and conflict management to assure effective interactions within and across departments
?Results oriented and possesses sound judgment
?Must be flexible and able to effectively manage multiple competing priorities
?An innovative, ?outside-the-box? thinker and leader, must have sound organizational skills
TECHNICAL KNOWLEDGE:Equipment: PC, scanners, voice mail, and email systems, and other common machines. Must have the ability to be trained on new equipment.
Software Knowledge:Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe.
ENVIRONMENTAL CONDITIONS:Physical Activities: While performing the duties of this job, the employee is frequently required to sit at desk for a long period of time; intermittently answer the telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The employee may need to use their hands to finger, handle, or feel objects, tools, or controls, and reach with their arms. The noise level in the work environment is usually low to moderate. The vision abilities required by this job include close vision and the ability to adjust focus.
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory Activities, if applicable: Experience with biological, animal, and chemical laboratory environments required. Environmental health and safety processes also apply.
||4215 Sorrento Valley Boulevard |
San Diego, CA 92121
THIS JOB HAS EXPIRED