post market qa analyst i

at Randstad US in waukegan, Illinois, United States

Job Description

post market qa analyst i.

+ waukegan , illinois

+ posted 5 days ago

job details

summary

+ $34 – $37.62 per hour

+ contract

+ bachelor degree

+ category life, physical, and social science occupations

+ reference48446

job details

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you’re looking to stand out in your field and lead the way to innovative therapies, this position is for you!

location: Waukegan, Illinois

job type: Contract

salary: $34.00 – 37.62 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

+ Initiate, investigate, and maintain complaint files following complaint handling regulation 21 CFR 820.198 and internal procedures. Analyze information obtained and make follow up calls to reporters.

+ Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when applicable) and computer files. Code complaint information according to Post Market Spreadsheet Report (PSR), Retrieval Program.

+ Assess incoming documentation, including clinical forms and medical information, for complaint data and ascertain compliance to product specification and/or intended use as indicated in the product labeling. Evaluate internal and external lab analysis. Coordinate with inter- and intra-departmental customers to ensure complaints and inquiries across product lines are handled appropriately.

+ Initiate Further Investigation and any additional follow-up and communication pertinent to the MDR as needed. Track files sent to Quality Assurance for Further Investigation and complete necessary documentation. Evaluate Further Investigation results, summarize findings, and determine and document the conclusion(s).

+ Assist Supervisors and Manager in monitoring complaint and claims workflow to ensure compliance and customer service.

+ Assist in resolving issues by responding to inquiries and answering technical questions regarding Company product line.

qualifications:

+ Bachelor’s degree with one to two years previous experience in customer service or clinical setting or equivalent combination of education and experience.

+ Customer service experience

+ Familiarity with Regulation pertaining to devices/510K (i.e. FDA, MHRA, etc.)

+ Flexibility in managing multiple tasks and expectations.

skills: SOP, FDA, Quality Assurance

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.