Senior QA Analyst
(Complaints) Senior QA Analyst (Complaints)
Johnson & ALZA Corporation develops drug delivery-based pharmaceuticals, precisely controlling the targeting, timing and
Johnson dosing of therapeutic compounds. ALZA technology has been incorporated in more than 30 commercialized
products, including DURAGESIC (fentanyl transdermal system) CII, CONCERTA (methylphenidate HCl) CII,
DITROPAN XL (oxybutynin chloride) and DOXIL (doxorubicin HCl liposome injection).
Vacaville , CA
ALZA Corporation is recruiting for a Senior QA Analyst position based in Vacaville, CA. The Senior QA Analyst
Status: will lead investigations for complaints received ranging from minor to major complexity and with potential product
Full Time, impact. The Senior QA Analyst will perform assessment with regard to quality impact and escalate as necessary
Employee based on procedures, the assessed criticality of the situation, associated compliance risk and potential impact to
product supply; will coordinate the investigation and compliant closure of complaints investigations; will make
Job Category: decisions with minimal guidance based on analysis of all available data and facts; will evaluate recommended
Quality corrective action and the need for preventative action; will make decisions and direct activities to ensure the
Assurance/Safety safety, purity and efficacy of the marketed product and will be responsible for the final disposition of the
complaints they are coordinating.
Reference Code: The Senior QA Analyst will trend complaints received and escalate potential compliance risks; will compile metric
28872 information, analyze data for trends, and lead improvement activities based on trending results. Metric data will
also be used for QPR and APR reports. The Senior QA Analyst will be required to compile and present
complaints investigations for Partner, Internal, and FDA audits, and any other regulatory agency requirements.
Primary responsibilities will include: Investigation and peer review of complaints; Trending of complaint data for
analysis, metrics, APR, QSMR, etc; Internal, partner, and regulatory agency audit support; Training (maintenance
of compliance and personal development).
A minimum of a Bachelors' degree and 5 years experience working in a Quality organization are required.
Bachelors' degree in science and pharmaceutical experience are preferred. In-depth experience working with
complaints/other quality related investigations is required. Ability to coordinate complaint investigation activities
through closure, and identification of compliance gaps with minimal guidance is required. Ability to make quality
decisions after evaluation of all facts is desired. Some experience with Leadership/negotiation skills is preferred.
Ability to multi-task and flexibility to shifting job priorities is required. Excellent verbal and writing skills required.
An analytical approach to problem solving is highly desirable. Experience with partner audits, internal audits and
FDA audits is highly desired. Solid understanding of cGMPS, FDA and EEC regulatory guidelines is required.
Weekend work may be required occasionally, and after shift and on call work may be required. This position is
based in Vacaville, CA.