Documentation; QC Specialist

Documentation (QC) Specialist

Location: New Brunswick, NJ

Duration: 12 months

Pay Rate: $54.44 - $59.44/hr on W2

Onsite Requirement: 50% onsite required

Work Schedule: Mon-Fri (normal business hours)

Responsible for management of commercial specifications and methods (internal release, stability, regulatory and compendial) and supporting documents for all client drug products, drug substances, intermediates, starting materials, excipients, reagents and packaging components. Includes quality assessment of change proposals to create new or revise commercial specifications and methods.

• Manage commercial specifications and methods to ensure clear, correct, concise, consistent, and compliant documentation.
• Review and execute change proposals for GTS documents.
• Perform quality approval of GTS documents.
• Maintain the GTS system, including managing notification templates and obsoleting documents that are no longer in use.

• Minimum of a bachelor’s degree required.
• Minimum 4 years experience in the pharmaceutical industry or related field.
• Cross‑functional experience in two or more areas (e.g., research, analytical/QC, QA, stability, supply chain, manufacturing, CMC, IT, etc.).
• Knowledge of specifications/methods, compendia, cGMP requirements, and regulatory expectations.
• Document management experience in a systems‑related environment.
• Experience with SAP or Lab Information Management systems.

• Ability to set priorities and deliver results independently.
• Customer and partner focus, including the ability to listen to and incorporate feedback (as appropriate) from key stakeholders.
• Ability to influence, initiate, and manage change.
• Organization awareness and ability to work well cross‑functionally with R&D, Regulatory, IT, etc.
• Detail‑oriented with a quality mindset.
• Strong verbal and written communication skills.
• Excellent meeting facilitation and project management skills.

Mid‑Senior level

Contract

Quality Assurance and Health Care Provider

Pharmaceutical Manufacturing