Quality Assurance Documentation Lead (Pharmaceutical Manufacturing)

Location: Onsite in Monmouth Junction, New Jersey, United States

Salary: $77,522–$101,750 per year, plus comprehensive benefits

Company

hirify.global is a specialty pharmaceutical company focused on researching, developing, and manufacturing OTC, prescription branded, and specialty generic products.

What you will do

• Support day-to-day quality assurance activities across laboratory operations, product development, technical services, engineering, production, packaging, QA operations, and IT.
• Maintain controlled quality documentation and support MasterControl processes, including document change requests, specifications, test methods, stability protocols, and master batch records.
• Monitor stability chambers, review chart recorder readings and calibration or preventive maintenance stickers, and document excursions or out-of-trend conditions.
• Manage stability samples, including pulls, transfers, labeling, chamber loading, stability requests, and chain-of-custody records.
• Issue, archive, and reconcile GxP records such as equipment logbooks, laboratory notebooks, and batch records.
• Collect APR data, coordinate sub-reports, host risk assessment meetings, document outcomes, and track recommended actions.

Requirements

• Bachelor’s degree in Chemistry, Statistics, Biology, or a related field.
• At least 3 years of relevant QA, laboratory, or pharmaceutical or biotech manufacturing experience with resin-based extended-release tablets, powders, or oral suspensions.
• At least 3 years of experience with cGMPs, quality documentation, SOPs, MasterControl, document change requests, and GxP physical records.
• At least 2 years of experience compiling APR data and collaborating with departments and subject matter experts.
• At least 1 year of experience with stability chambers, SLIM database workflows, stability samples, and APR schedules.
• Fluent written and verbal English is required. Ability to distinguish colors, lift up to 30 lbs, and use personal protective equipment is also required.

Culture & Benefits

• Full-time employment with comprehensive benefits.
• Work in a fast-paced, matrixed environment with internal and external teams.
• Collaborate with cross-functional departments and subject matter experts.
• Background checks, including drug screening, may be required.