Document Control Specialist (2nd Shift)

About the role

This position ensures the accurate, compliant, and timely release of finished product placed on electronic quality hold. Working under Operations Quality leadership, the role focuses on verifying documentation, reconciling lot and batch records, coordinating with manufacturing and warehouse teams, and certifying data in SAP to support safe and efficient product release in a regulated environment.

Responsibilities

• Verify electronic transactions for consistency and accuracy against corresponding paper documents.
• Ensure non-conforming material (NCM) information is updated, accurate, and properly documented in relevant systems and records.
• Place processing certifications into the device history record (DHR), lot file, or batch record to maintain complete and compliant documentation.
• Supply and record the quantity for each lot and maintain a running balance in the DHR or lot file/batch record.
• Perform final review of the DHR, including reconciliation of records, confirmation that any NCM has been closed, and completion of file close-out activities.
• Investigate and resolve discrepancies in documentation or product status by collaborating with Manufacturing and Warehouse departments.
• Research, verify, and reconcile product information received from sterilization vendors and third-party distributors.
• Verify and certify information entered into the SAP system before releasing product from quality hold.
• Identify and recommend process and workflow improvement opportunities to minimize the time product remains on Quality Hold.
• Escalate complex or unresolved issues to the Quality Manager in a timely and clear manner.
• Maintain strong document control practices and support quality control and quality assurance activities in alignment with GMP and ISO procedures.
• Work effectively within a team environment, contributing to a culture of accuracy, accountability, and continuous improvement.

Requirements

• Minimum of a high school diploma or GED.
• Prior job experience in a quality-related position with a solid understanding of lot file documentation and good documentation practices.
• Experience working with GMP and ISO procedures in a regulated environment.
• Ability to perform detailed batch record and DHR review, including reconciliation and close-out.
• Proficiency or working knowledge of SAP, particularly SAP QM, for product and quality data verification and certification.
• Strong communication skills, with the ability to clearly document findings and collaborate with cross-functional teams.
• Ability to work successfully under a high level of scrutiny and accountability while maintaining accuracy and compliance.
• Demonstrated ability to work well with others in a team environment.
• Ability to adjust quickly and efficiently to changing operating conditions and a fast-paced work environment.

Skills

• Proficiency in SAP QM system is preferred.
• Certification by ASQ (such as quality-related certifications) is a plus.
• Experience in document control, quality control, or quality assurance is highly beneficial.
• Experience with batch record review and reconciliation in manufacturing or distribution settings.
• Familiarity with quality hold processes and product release procedures.
• Strong problem-solving skills for investigating discrepancies and coordinating resolutions with internal and external partners.

Work Environment

This role operates in a regulated quality and manufacturing environment, working closely with Operations Quality, Manufacturing, Warehouse, and external sterilization vendors and distributors. The position is scheduled on a second shift, typically from 3:30 p.m. to 1:00 a.m., supporting continuous operations and timely product release. Work involves frequent interaction with electronic systems such as SAP, as well as review of paper-based documentation, batch records, and device history records. The environment is fast-paced and detail-oriented, with a strong focus on compliance with GMP and ISO procedures, accuracy in documentation, and collaboration across teams.

Pay

The pay range for this position is $20.00 - $20.00/hr.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This role is scheduled on a second shift, typically from 3:30 p.m. to 1:00 a.m.

This is a fully onsite, contract position based in Asheville, NC.