Product Maintenance and Compliance Technician Job

PRODUCT MAINTENANCE AND COMPLIANCE TECHNICIAN needed for a contract hire opportunity with Yoh's client located in Ridgefield, CT.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Entry Level Job Opportunity! Seeking candidates with interest in the Pharmaceutical Industry.
- Strong eye for detail especially pertaining to Document Review and Submissions
- Accurate Data Entry

WHAT YOU'LL BE DOING:

- Assist Specialists in compiling information required for any type of post-marketing submission (link archived reports, create virtual documents, scan cover letter and FDA forms, and send distribution)
- Assist with publishing all routine submissions (e-promo, establishment registration and drug listing)
- Assist with QC of submissions for compliance with FDA/ICH Guidelines and/or internal SOP/WIs (check submissions for completeness)
- Assist Manager/Associate Director by collecting FDA communications (in Service, Product Maintenance Mailbox, IDEA Archive Search) and perform data entry activity an appropriate information into the TRAC database (Oracle). Provide TRAC database reports to requestors.
- Prepare submissions for formal archiving and submit to Regional Archive Center (prepare travel forms; completed attributes and promote in IDEA)
- Work with necessary external departments (ie Central Printing, Mailroom, etc.) to ensure that submissions are completed and ready to ship by deadline; follow-up as necessary to assure timelines are not compromised
- Check submission content for format, completeness, legibility, cross-referencing, accuracy, signatory approval and compliance with regulations and/or internal guidelines

WHAT YOU NEED TO BRING TO THE TABLE:

- Associates or Bachelors degree
- One to two (1 - 2) years of pharmaceutical industry experience within a regulatory environment preferred
- Accurate document review and data entry skills
- Ability to perform diverse and moderately complex tasks with supervision
- Complete tasks utilizing current document management, compilation and publishing hardware/software
- Experience assisting with post-approval maintenance projects
- Applies knowledge/skills to a range of post-approval activities; acts as a technical resource to others.
- Manages own time to meet objectives.

GET HIRED, APPLY NOW!

RECRUITER: Hanna Pride

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: ENGJ2WNWPHA

Ref:

SFSF: ENG