Title: Safety & Regulatory QC Location: Collegeville, PA Schedule: Hybrid 2 days/week on site: 3 days/week remote Start date: ASAP Contract: 12 months; possible extension Overview Our Clinical Partner has an opening that can be located within driving distance to Lake Forrest, IL, Groton, NY, or Collegeville, PA. The ideal candidate will have experience in quality document control, comparison of artwork versus editor's copy and supporting documentation. Support in one or more ALIM regional leads will be required as well as verification. Please apply! Responsibilities:
Verify information in final printed secondary packaging component artwork against Editors copy documents for accuracy and consistency.
Involves technical review of secondary packaging components across multiple markets (languages) worldwide according to specifications and trade dress requirements as outlined in SOPs.
Liaises with Worldwide Safety & Regulatory (WSR) Country Offices, Global Labeling Management (GLM), the geographically distributed artwork centers within Global Supply (GS).
Provide document verification proofing of packaging and labeling artwork versus Editors Copies (ECs) to assure compliance with required local country (and/or regional) format and style guidelines.
Evaluate packaging and labeling artwork updates, interpret information and ensure that changes have been applied consistently across products and product lines.
Requirements:
Bachelors degree
2 years experience in proofing pharmaceutical labeling, packaging components or medical/scientific documents.
Strong editing/prooing skills, including broad vocabulary and knowledge of medical/scientific terminology.
Attention to detail and ability to focus attention for long periods of time.
Robust text comprehension and ability to identify and mark errors in typography, spelling, word usage, style, punctuation and grammar. Ability to apply these skills across multiple languages, especially non-native language is highly desirable.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.