Document and Records Management Specialist

A clinical stage biopharmaceutical company on a rapid path to commercialize its proprietary applicator-free, dissolving, microarray patch technology designed to achieve better health outcomes through enhanced therapeutic effects, simplified logistics, and improved patient compliance. Join this team of Scientists and Engineers to make a difference in Health care! PERM role!! EXCELLENT BENEFITS!!

Summary: We are currently seeking a highly skilled and detail-oriented Document and Records Management Specialist to join our dynamic team. As a Document and Records Management Specialist, you will develop and maintain document and record control systems in the FDA regulated biologics, pharmaceutical, and medical device industries.Responsibilities:Maintain document control systems (electronic/paper) compliant with regulatory/standards requirements and company procedures/systems.Maintain external documents compliant with regulatory/standards requirements and company procedures/systems.Maintain record control systems (electronic/paper) compliant with regulatory/standards requirements and company procedures.Maintain specimen, and reference and retention sample control systems compliant with regulatory/standards requirements and company procedures/systems.Maintain training matrices (electronic/paper) compliant with regulatory/standards requirements and company procedures.Provide expertise and input to other functional areas including but not limited to Engineering, Research, Development, Quality, Production regarding documents, specimens/samples, and good data recording practices (ALCOA+).Creates, reviews, and approves documents – procedures, protocols, reports, etc.Quality assurance review and disposition of products.Represents Quality on intra-/inter-departmental project teams.Conduct company-wide training (e.g., documents, records, and specimens/samples).Conducts internal and supplier audits.Ensures in a positive way compliance with regulatory/standards requirements and company procedures.Participates in professional organizations to ensure that state-of-the-art industry regulatory/standards requirements are communicated within the company and implemented in an efficient, timely, and accurate manner.Manages projects as assigned.Maintain and present quality indicator metrics.Has some independence for unreviewed action or decision.Effectively manage time and multiple task assignments.Other duties as assigned by management.Qualifications:Education:Bachelor (or equivalent) degree in English/Technical writing with ≥5 years’ experience with document and records control in regulated industry.Experience:5 or more years’ experience in document and records control.Working knowledge and experience with GMP or QSR / ISO 13485 or ISO 9001 required; GLP, GCP, and related ISO and ICH preferred.Working knowledge and experience with paper-/electronic-based document management systems.Excellent communication skills (oral, written, and presentation) and understands how to present information dependent upon the level of the audience.Must be detail oriented with excellent organizational skills.Must be able to work independently as well as in a team environment.Expert: MS Word, MS Excel, MS Power Point, Adobe and/or Adobe Creative Suite.Design/create product labels, product labeling (e.g., IFU, product inserts), audio-visual trainingsAbility to work independently and collaboratively in a fast-paced environment