Job Description

TS Conductor is hiring a Document Control Specialist to keep our quality system audit-ready and make sure every procedure, record and change is current, controlled and easy to find. We hire on what you have already achieved, so we care more about the results you have delivered than the titles you have held.

In this role you keep our documents organized, updated and ISO-compliant, and you run day-to-day Quality Systems work: supplier qualification, deviation management, change management and document control. You help make sure TS Conductor operates in line with current Good Manufacturing Practices and regulations and with ISO 9001:2015 and other ISO standards.

What you will accomplish

Document control and records

• Own the intake, handling and storage of documents, uploading or scanning paper documents into our document management software so every record is organized and current.
• Develop and implement document control processes, and make sure all documentation meets formal requirements and standards.
• Track and manage document versions, review and update documents as needed, and confirm that proposed changes to procedures or records comply with the quality system standard.
• Keep the work instructions and SOPs for every area of the company under document control.
• Retrieve files for authorized staff, secure backup and storage that meets laws and regulations, and keep all documentation discoverable and accessible.

Change control, deviations, CARs and NCRs

• Manage changes generated in the quality system and keep the information updated and available in the system.
• Work with departments to complete deviation investigations, CARs, change controls and NCRs, and make sure documents are complete, accurate and up to date.
• Control communication documents with clients and suppliers, such as corrective actions, NCRs and deviations.

Supplier qualification

• Maintain the supplier qualification program: evaluate supplier self-audit questionnaires, track supplier performance and establish quality agreements and clauses.
• Assist the audit team during site quality system audits.

Audits and compliance

• Participate in internal, external, third-party and regulatory audits and provide responses as needed, including as a member of the internal audit team.
• Supervise and ensure compliance with document control procedures and policies.

Metrics, calibration and labels

• Collect monthly results from each department and produce the monthly metrics report.
• Review the status of external calibration equipment and tools, coordinate their collection when required, and keep track of calibration and safety labels.

Projects and improvement

• Support project team activities and investigations, take part in process improvement projects, and handle additional duties as assigned.

What we offer

• Medical, dental, life insurance and long-term disability, starting the first of the month after 30 days of employment.
• Paid time off (sick and vacation) and 10 company holidays.
• 401(k) with company match.
• Referral rewards program.

What you bring

• You have 1 to 5 years in a quality department and can point to work you owned. Be ready to talk about:
• A document control system you ran, built or fixed, with a before-and-after result.
• A change control, deviation, CAR or NCR you drove to closure across several departments.
• A supplier qualification or audit you supported, and the outcome.
• Data you collected and turned into a report others relied on.
• Requirements
• 1 to 5 years of experience in a quality department, including document control and internal audits.
• Experience with a document control system that maintains and processes document revisions approved through change control.
• Knowledge of ISO 9001:2015, and of digital applications, file formats and design limitations.
• Proficient with Microsoft Office and with Windows, Mac or other technical tools.
• Excellent written and spoken communication: explains programs, policies and procedures in plain language, understands the impact of a message on the organization or customer, and works well with internal leaders, suppliers and customers.
• Excellent attention to detail, problem-solving skills, a strong work ethic and a commitment to high-quality, data-driven work.
• Able to organize and prioritize resources, bring in new information to reach the most effective solution, and manage several tasks at once in a fast-paced environment.
• Works well independently and as part of a team.
• Able to pass an E-Verify background check.
• Preferred
• Bachelor's or associate degree in a technical, business, management, science, computer science, manufacturing or related field.
• Licenses or certifications: ISO, FDA, SQF, PO, MO, APICS, ASQ, 9001, GMO or Lean.

Work Environment

This role combines settings: the office, the quality control lab and a safety-sensitive manufacturing environment. You will spend time on the shop floor, near and around large-scale production processes and equipment, meeting production teams and observing how work is actually done so that procedures, work instructions and records match real practice.

You will work with Research and Development (R&D) and Quality Control Testing so that new manufacturing processes, tests and experiments are documented, controlled and compliant with standards. In the quality control lab you will document results, analyze data, create instructions and collaborate with others.

Occasionally you will join on-site visits to suppliers, vendors or customer sites to support supplier qualification and review quality issues.

Occupational health and safety practices are essential in manufacturing. You are expected to follow safety protocols and wear appropriate protective equipment when necessary.