Quality Assurance Technician

Actalent•Orangeburg, NY

37d•$55,000 - $60,000•Onsite

About The Position

Perform daily inspections of all production lines to ensure compliance with Good Manufacturing Practices (GMPs) and company standards. Accurately document all inspection details, including incoming lot numbers, liquid lot numbers, item numbers, fill weights, and defects. Ensure that all manufacturing specifications for components, labeling, and products are correct, clear, and complete. Inspect work areas for removal of all previous products and components and verify readiness prior to use.

Requirements

Quality assurance and inspection experience.
Minimum of 3+ years of quality experience in a regulated environment.
Strong understanding of GMPs, quality systems, and regulated manufacturing environments.
Working knowledge of AQL inspection standards, sampling plans, and in-process quality control methods.
Familiarity with batch documentation, manufacturing specifications, and component/label verification.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
Ability to learn and operate quality-related systems such as LIMS, ERP, and electronic documentation tools.
Demonstrated experience performing in-process quality inspections, line clearances, material disposition, and documentation review.
Experience supporting trials, validations, rework activities, and sample collection.
Prior exposure to continuous improvement, deviation identification, and collaboration with Production/Quality teams.
Strong ability to interpret and follow SOPs, Work Instructions, Master Batch Records, and product specifications.
Excellent documentation accuracy, attention to detail, and commitment to 'first-time-right' execution.
Effective communication skills with the ability to escalate discrepancies and collaborate across teams.
Solid organizational, multitasking, and time-management skills.

Nice To Haves

Associate's Degree in a scientific, technical, or related field, or equivalent combination of education and experience.
Ability to take initiative and identify improvement opportunities.
Excellent organizational and leadership skills.

Responsibilities

Monitor, sample, and inspect in-process finished products for quality by performing appropriate tests.
Collect data and samples to support the disposition of products.
Determine final disposition of inspected products and verify information on transfer tickets.
Apply appropriate disposition labels to materials.
Identify and notify Production and Quality teams when discrepancies from procedures and specifications are observed.
Perform AQL inspections as required.
Execute rework protocols as needed.
Initiate and log LIMS and retain samples.
Print specifications from ERP systems, create shop order packages, and provide them to Production as needed.
Collect samples required by customers or PDI specifications and ship samples accordingly.
Collect stability samples.
Execute trials and validations.
Review documentation for accuracy before submitting to the QA Release team.
Review Master Batch Records and act as Lead QA Inspector in their absence.
Identify continuous improvement opportunities and promote a culture of quality.
Handle assignments to establish and maintain product quality.
Perform required testing as per SOPs and WIs.