Document Control Specialist II

Core Hours: Monday - Friday, 8am-5pm

Purpose and Scope

The Document Control Specialist II supports Tolmar by performing functions involving the processing of controlled documents and maintenance of the Document Control system under limited supervision.

Essential Duties & Responsibilities

• Issue batch records and associated documents including copy verification.
• Navigate in the Tolmar Network drives for storage of electronic documents, as applicable.
• Update and maintain associated databases and tracking systems including, batch record issuance, lab notebook issuance and archival and validation document numbers.
• Ensure employee signature cards are scanned, filed and stored in secured location for review by departments to verify signature.
• Maintain electronic and paper copy files, as needed per the retention schedule.
• Coordinate and prioritize scanning of files and other documents/records ensuring proper retention requirements including Department document submissions, laboratory notebooks, batch records, logbooks and QA receiving paperwork.
• Perform the daily Document Distribution activities. Maintain document/file room processes, including filing of documents.
• Process all electronic document system types ensuring company-wide adherence to procedures. Complete Electronic Document Management System formatting reviews for documents. Aid all levels of personnel/management regarding the creation and revision of documents within the document management system.
• Assist with revision of department assigned documents.
• Maintain and submit supply requests for the document control department.
• Escalate and ensure open communication when discrepancies are found in any work.
• Own procedures within department and perform revisions of documents outside of department.
• Provide full training of team members on processes and tasks as necessary to complete daily duties per procedure.
• Perform department deviations, investigations, immediate actions, corrective actions or change controls, as identified within the Electronic Quality Management System.
• Complete the quality check requirements for documents in the Electronic Document Management System.
• Process purchase orders and requisition requests for the document control department in Enterprise Resource Planning software.
• Support and participate in Quality Systems or multi-department projects as a Subject Matter Expert for document control.

• Continually improve and maintain appropriate document retention requirements. Perform initial assessment of documents that have exceeded retention requirements. Initiate destruction of documents, as required
• Perform other duties as assigned.

Knowledge, Skills & Abilities

• Extensive knowledge of Microsoft Word, Excel, PowerPoint, Access, and Acrobat Adobe.
• Knowledgeable in FDA Good manufacturing Practices (cGMP).
• Excellent organizational skills.
• Ability to maintain focus on detail-oriented, repetitive tasks.
• Effective verbal and written communication to support a broad range departments.
• Ability to interact with management, peers and members of other departments in team settings in a respectful and professional manner.
• Veeva experience is preferred.

Core Values

The Document Control Specialist II is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• High school diploma or GED required.
• Some college coursework preferred.
• Three or more years of experience in an administrative position required, preferably in a pharmaceutical or medical device environment.
• Experience in Document Control preferred.

Working Conditions

• Working conditions are normal for an office environment.
• May require occasional overtime.

Compensation and Benefits

• Pay: $27.25 - $28.25 per hour, depending on experience
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.