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 trainings
• Ability to work independently and collaboratively in a fast-paced environment