Document Control Specialist Quality Assurance

You will own the electronic Quality Document Management System (QCBD) at a Dallas medical device manufacturer. You will process Engineering Change Orders for Manufacturing Specifications and SOPs, support Corrective and Preventive Actions, Nonconformances, and OOS, and ensure compliance with ISO 13485:2016. You will work directly with the Quality Manager during customer and regulatory audits, and drive special projects. This role offers a launchpad into Quality Management or Regulatory Affairs, with full ownership of document control processes from day one.

KVK Tech seeks a Document Control Associate to lead GMP documentation management. The ideal candidate will own controlled document processes and ensure regulatory compliance across pharmaceutical operations. This full-time onsite role in Philadelphia offers competitive compensation and benefits.

QA Specialist I owns document control and raw material release for a biopharmaceutical CDMO manufacturing gene therapies at clinical and commercial scale. You will ensure cGMP compliance across viral vector and plasmid production, reporting to the QA Manager and partnering with manufacturing operations. This role anchors the quality system for a company founded by gene therapy patients, with work directly impacting life-saving treatments. You will drive document control, internal audits, and metrics that keep the Quality Management System audit-ready for FDA and FACT standards.

Contract Document Control Specialist supporting Pharmaceutical Biotech clients in Boston area. Manage GMP documentation lifecycle ensure accuracy compliance through tracking reconciliation distribution and archival. Provide confidential secure handling of controlled papers.

You will own the global Quality Management System at Corbus Pharmaceuticals, a clinical-stage oncology and obesity biotech. Reporting to the Senior Director of Quality, you will lead Document Control, CAPA, Deviations, Change Control, and Training, ensuring inspection readiness across GxP environments. You will partner cross-functionally to embed quality as a strategic enabler, scaling systems as the organization grows. This hands-on role blends strategic vision with operational execution, driving continuous improvement and commercialization readiness. You will serve as Quality System Owner for the eQMS, ensuring validation and compliance with Part 11, Annex 11, and CSA.

Own the quality systems that protect every batch of cell therapy product released from this Sacramento facility. You will manage deviations, change controls, CAPAs, and document control while making batch disposition decisions that keep production moving. Working within a cross-functional team of manufacturing and quality control professionals, you will ensure compliance with FDA regulations and cGMP standards. This contract role offers the chance to apply your quality expertise directly to next-generation therapies, with the flexibility of hybrid work after an initial on-site period.