Bulk QA Lab Technician: Batch Release & Testing

Job Summary

The QA Bulk Laboratory Technician is responsible for examining bulk batches coming from Compounding; if out of specification, it provides instructions to Compounding to remediate, releases or rejects batches, and maintains a safe working environment. It follows safety guidelines and GMPs related to personal hygiene and handling of raw materials and equipment in order to maintain safety standards.

• Provide technical, customer relations, and personnel management for major programs and projects.
• Test bulk batches versus standards and specifications, adjust batches within specification if required, and release or reject as appropriate.
• Replace stability samples in the stability‑chamber at appropriate temperatures, test stability samples according to schedules, and report problems or failures to the R&D Manager.
• Calibrate laboratory instruments daily; keep external calibrations up‑to‑date, including viscometers and certified thermometers annually.
• Test line start‑up samples as soon as possible so Production can start a line.
• Keep notebooks up‑to‑date and signed according to GMP regulations.
• Review raw material test data and, if all specifications are met, release materials in the warehouse management system.
• Give bulk micro samples to the Micro group for testing, if needed.
• Send out samples to customers for approval before shipping them, and create Certificates of Analysis for bulk products sent to other companies.
• Keep laboratory dye inventory up‑to‑date by sending dyes expiring within one month out for micro testing, and order additional dye from Sayreville before inventory expires.
• Test samples from external contract manufacturers.
• Prepare chemical solutions as needed, including acids, bases, and dyes, for laboratory adjustments.
• Change stability‑chamber charts monthly.
• Change status of finished goods in the Warehouse Management System as needed.

Education

Bachelor Degree in a related science field.

Experience

1‑year experience in a related manufacturing position.

Skills

• Excellent communication (verbal and written) and organizational skills. Detail‑oriented.
• Ability to read and interpret technical procedures and specifications; present information and respond to questions from management and inter‑department staff.
• Ability to work effectively with peers and associates from other departments.
• Ability to engage and lead individual and team discussions and meetings.
• Mathematical competency: add, subtract, multiply and divide into all units of measure, using whole numbers, common fractions, and decimals.
• Ability to work with little supervision and use independent discretion.
• Ability to operate computerized lab equipment and maintain accurate data/records.
• Strong analytical and problem‑solving abilities.
• Team‑oriented and able to work independently or in a collaborative setting.
• Flexible, adaptable, and capable of working in a fast‑paced environment.
• Consistent application of relevant policies in a timely and objective manner.
• Ability to handle multiple tasks and shift priorities as necessary; uses time effectively.
• Gathers and analyzes information skillfully.
• Proficient use of MS Office (Word, Excel and Outlook).

Most important decisions made fully independently:
Determines acceptability of bulk batches.

Most important decisions made with review and approval of other individuals or supervisors (include the reviews/approvals required):
Approve or reject bulk batch results.

• Regularly required to sit, stand, walk, and use hands and fingers to operate a computer keyboard, mouse, and telephone.
• Frequently required to reach with hands and arms, climb or balance.
• Occasionally required to stoop, kneel, crouch or crawl and lift up to 25 pounds.
• Specific vision abilities required: close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• Primarily works in a manufacturing and laboratory environment; may require travel for company events, staff meetings, training sessions and vendor fairs. Personal vehicles may be used for business travel with long periods of sitting.
• Noise level in the work…