Description

Perform in-process quality checks—including weight,

thickness, hardness, disintegration, and friability—according to instructions

in the manufacturing batch record. Conduct pre-manufacturing inspections of

rooms and equipment by following detailed written procedures. Carry out

Acceptable Quality Limit (AQL) sampling and inspections as required. Inspect

in-process and finished product samples (where applicable) for the Quality

Control (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 batch

processing. Monitor environmental conditions affecting both facility and

product quality. Review engineering documentation, including

temperature/humidity logs, calibration and preventive maintenance (PM) records,

pest control logs, and contractor activity reports. Evaluate online batch

records for completeness, including signatures, entries, and reconciliation/yield

accuracy before proceeding to the next processing step. Confirm the

functionality of all equipment and control systems during batch runs. Conduct

relevant testing and prepare reports in response to customer complaints.

Identify and escalate any non-conformances or discrepancies to management as

needed. Perform additional duties or participate in special projects as

assigned by management.

Skills

Quality assurance, Gmp, capa, sap, document control,

pharmaceutical manufacturing, change control, deviation, batch record, mdi,

document management, hplc

Top Skills Details

Quality assurance, Batch Record Review

Additional Skills & Qualifications

A minimum of 2-3 years of experience in quality assurance

within a GMP-compliant pharmaceutical manufacturing environment conducting

batch record review from an office setting and not the production floor.

Experience with internal OOS and OOT investigations bachelor's degree preferred

Pay and Benefits

The 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 days

Workplace Type

This is a fully onsite position in Central Islip,NY.

Application Deadline

This 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 for other accommodation options.