Quality Specialist II, Post Market Surveillance and Stability

Advantage Technical
$37.00-$42.00
paid time off, paid holidays
United States, California, Canoga Park
April 28, 2024
Advantage Technical is seeking a talented and passionate Quality Specialist II for our great global client in Canoga Park, CA. It's a long term, 12-month contract that would look great on your resume! Do you have what it takes? Quality Specialist II, Post Market Surveillance (PMS) and Stability will provide support in preparation of data analysis, reporting, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews and review and closure of certain categories of complaints. It requires regulatory assessment capability along with MDR/Vigilance reporting. The Post Market Surveillance Specialist may also review and monitor data and document quality, as requested by the manager. Key Responsibilities: Product Complaints: The duties and responsibilities include, but are not limited to the following: Review and analyze lot documentation (DHRs) to determine if there are any anomalies that may have related to reported product failures. Perform basic product review and failure analysis. Prepare risk management plan, facilitate risk analysis and assessment per Risk Management Policy, monitoring and compiling data from adverse events, customer inquiries, complaint records, CAPAs, deviation reports, stability reporting, non-conformance reports, PERs, PCRs, recalls, scientific literature searches, clinical performance, and proficiency testing. Product Stability: Coordinates and performs various stability testing in accordance with stability protocols. Ensures stability samples are available and placed in stability chambers at the appropriate time frames to meet the requirements of the stability protocol. Ensures stability samples are pulled at the appropriate time frames to meet requirements of the stability protocol. Analyzes stability test data utilizing the department stability software program. Assists Risk and PMS manager with summarizing stability data for submission into the final stability report. Ensures testing and data analysis is completed in a timely manner to meet business and regulatory deadlines. Identifies Out of Specification results and notifies manager in a timely manner. Notifies manager immediately when adverse stability data trends are identified. Ensures stability chambers are maintained and calibrated according to internal and external quality and regulatory requirements.Product Development Risk Review: Document and facilitate product development and change risk reviews. Assist with Post Market Surveillance department functions as needed. (Specific duties may vary and will be documented in department records, job assignments and/or project action items). Perform computer operations for data entry and provide tracing/trending reports. Abide by corporate policies, procedures and work instructions. Assist during FDA, ISO or other third party or internal audits. Other duties as assigned. Minimum Requirements: Bachelors degree in Biological Sciences or a related field. 2 years of experience in a Quality regulated environment. Able to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications. Exact Schedule - 830am -530pm M-F The base pay range above represents the low and high end of the base compensation range we reasonably expect to pay for this position. Actual base compensation will vary and may be above or below the range based on various factors including, but not limited to, geographic location, actual experience, and job performance. This job posting is not a promise of any specific pay for any specific employee. The range listed is just one component of the total compensation package for our employees. Based on the details of your position, we provide a variety of benefits to our employees, including medical, dental, and vision plans, pre-tax savings plans, pre-tax parking and commuter plans, supplemental health and welfare plans, a retirement savings plan, an employee assistance program, pet insurance, and paid holidays. Other rewards may include short-term incentives and paid time off. After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play. About Advantage Technical With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit . Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment. All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.