Quality Control Analyst

EPICUR•Mount Laurel Township, NJ

7h•Onsite

About The Position

The Quality Control Analyst I Manufacturing ensures that materials and finished drug products are manufactured in accordance with current Good Manufacturing Practice (cGMP) requirements and Epicur Pharma standards. The position performs inspections and in-process checks, documents testing and inspection results, supports sample management and quality documentation, audits manufacturing operations, and contributes to corrective and preventive actions and change controls. The role operates primarily in a controlled manufacturing environment and requires frequent standing and walking.

Requirements

High school diploma or GED.
Able to wear required protective gear, including gown, hair bonnet, mask, beard cover, gloves, and goggles.
Able to follow gowning and garbing procedures, including removing jewelry and not wearing makeup in the manufacturing area.
Strong verbal, written, and oral communication skills.
Ability to work independently and as part of a team.
Ability to recognize priorities, take action, and use time productively.
Punctuality and low absenteeism.
Able to sit and/or stand for 8–10 hours or more per day as needed.
Fluent in reading, writing, speaking, and understanding English, and able to read and interpret operating and maintenance instructions and procedure manuals.
Able to perform basic arithmetic with whole numbers, decimals, and fractions when checking reports, forms, records, and comparable data.
Able to interpret written, oral, diagram, or schedule instructions and address concrete variables in substantially standardized situations.
May need to lift up to 25 pounds on occasion.

Nice To Haves

Familiarity with cGMP and 21 CFR Part 210 and 211; preferred but not required.

Responsibilities

Inspect incoming materials intended for use in drug product manufacturing.
Perform in-process quality checks and inspect finished drug products to ensure standards are met.
Assist with documenting and maintaining material and product samples, including retains, stability samples, and finished product samples.
Review logbooks for accuracy and good documentation practices.
Document inspection and testing results by completing QC reports and logs.
Conduct random audits of manufacturing operations to verify compliance with quality standards and SOPs.
Participate in executing and verifying corrective and preventive actions (CAPA) and change controls.
Complete and review batch record documentation for quality release of finished product.