Document Control Specialist

Smithers PDS LLC (Pharmaceutical Development Services) offers a comprehensive range of preclinical and clinical services for all phases of drug development including support for development of drug delivery devices and medical and pharmaceutical packaging testing. Our expert scientists perform large molecule bioanalysis assay development validation and sample analysis at our GLP GCP and CLIA compliant laboratories.

Smithers is seeking a talented Document Control Specialist to join our team. The Document Control Specialist manages and maintains company documents ensuring accuracy compliance with regulations and easy accessibility. This includes organizing storing and retrieving documents both physically and electronically and tracking revisions and updates. This role ensures that documents are properly archived and disposed of according to company policy.

Responsibilities include (but are not limited to) the following:

• Oversee the organization accessibility and security of documents in both digital and physical formats.
• Maintain consistent filing structures metadata tagging and indexing for easy retrieval and management of documents.
• Ensure that document changes updates or revisions are approved properly tracked and recorded in the system and distributed.
• Maintain documents according to internal guidelines and policies and regulatory requirements.
• Protect sensitive information by adhering to security protocols for document storage and distribution.
• Provide quick and efficient access to documents as requested by team members clients or stakeholders.
• Support archival of documents for completed projects in a manner that allows for easy retrieval if needed later.
• Conduct internal audits of documents. Prepare and provide documents for external audits and records requests.
• Create and/or distribute reports related to document status compliance and tracking for management and auditing purposes.
• Handle requests for document access ensuring that only authorized personnel have access to restricted or sensitive documents.
• Manage the creation and build out of folder structures.
• Collaborate to identify improvements to document control processes and help implement them. Support continuous improvements.
• Perform quality control checks of project documentation for accuracy and compliance with internal standards correcting any errors found in version tracking or documentation.
• Work closely with relevant functional teams and stakeholders to implement tools or enhancements within the document management system (DMS) that streamline processes.
• Oversee the creation approval revision archiving and eventual disposal of documents ensuring full lifecycle management and retention schedules are adhered to.
• Address and resolve document control issues that involve discrepancies system failures or noncompliance escalating critical problems as needed.
• Collaborate with various departments to ensure document control processes align with project goals and organizational standards.
• Train and assist team members in the use of document management software.

Skills and Attributes

• Possess excellent verbal and written communication skills.
• Possess excellent multitasking and organizational skills with supreme attention to detail.
• Possess excellent collaboration skills.
• Customer Focus Makes customers and their needs a primary focus of ones actions; develops and sustains productive customer relations.
• Contributes to Team Success Actively participates as a member of a team to move the team toward the completion of goals.
• Builds Trust Interacting with others in a way that gives them confidence in ones intentions and those of the organization.
• Results Achievement Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
• Safety Awareness Identifies and corrects conditions that affects employee safety; upholds safety standards.

Minimum Qualifications

• High School Diploma or equivalent. Bachelors degree in Science Business Administration Project Management or related field preferred.
• 3 years work experience as a Document Control Specialist and Archivist in a regulated biopharmaceutical contract research environment.
• Knowledge of records management procedures and standards.
• Understanding of FDA regulations for GLP.
• Understanding of security protocols and the management of sensitive/confidential information.
• Proficiency with industry standard document control software.
• Proficiency with Microsoft Office (e.g. Outlook Word Excel PowerPoint etc.

Salary for range for this position is $60000 $70000 per year. Salary and job title will be commensurate with experience and qualifications. Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans dental insurance vision insurance 401K retirement plan and PTO.

Required Experience:

Unclear Seniority