Quality Assurance Associate II Position Available In Suffolk, New York

Job Order Number:

DG0192426

Job Title:

Quality Assurance Associate II

Company:

Actalent Location:

Central Islip, NY

Salary:

Education:

Information Not Provided

Experience:

Information Not Provided

Hours:

Duration:

Full Time, Regular

Shift:

Description:

 DescriptionPerform in-process quality checks-including weight,thickness, hardness, disintegration, and friability-according to instructionsin the manufacturing batch record. Conduct pre-manufacturing inspections ofrooms and equipment by following detailed written procedures. Carry outAcceptable Quality Limit (AQL) sampling and inspections as required. Inspectin-process and finished product samples (where applicable) for the QualityControl (QC) Lab, ensuring accurate documentation and timely delivery of results.

Maintain standard weight records and perform daily balance verifications.

Properly isolate and document any rejected materials generated during batchprocessing. Monitor environmental conditions affecting both facility andproduct quality. Review engineering documentation, includingtemperature/humidity logs, calibration and preventive maintenance (PM) records,pest control logs, and contractor activity reports. Evaluate online batchrecords for completeness, including signatures, entries, and reconciliation/yieldaccuracy before proceeding to the next processing step. Confirm thefunctionality of all equipment and control systems during batch runs. Conductrelevant testing and prepare reports in response to customer complaints.

Identify and escalate any non-conformances or discrepancies to management asneeded. Perform additional duties or participate in special projects asassigned by management.

SkillsQuality assurance, Gmp, capa, sap, document control,pharmaceutical manufacturing, change control, deviation, batch record, mdi,document management, hplcTop Skills DetailsQuality assurance, Batch Record ReviewAdditional Skills & QualificationsA minimum of 2-3 years of experience in quality assurancewithin a GMP-compliant pharmaceutical manufacturing environment conductingbatch record review from an office setting and not the production floor.

Experience with internal OOS and OOT investigations bachelor’s degree preferredPay and BenefitsThe pay range for this position is $65000.00 – $73000.00/yr.benefits start day 1 and they are eligible for 2 weeks vacation, 56 hours sick and wellness add 2 days mental health daysWorkplace TypeThis is a fully onsite position in Central Islip,NY.Application DeadlineThis position is anticipated to close on Jul 3, 2025.About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.