Job Description

Job Description
Primary responsibilities of this role include the following:
With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside of the US.
Support Drug Product Complaint management; forwarding to respective drug product manufacturing site and coordinate with corporate QA for investigations.
Support Drug Product Recall/Field alert management.
Assist with review of Quality Agreements.
For applicable products, coordinate with Contract Testing Laboratories for Analytical Method Transfer activities, Drug Product testing, any OOS results, and test method issues.
With supervision, review deviations/investigations related to Strides Pharma Inc. (Strides) frontend products.
Assist with SOP management for Strides’ US corporate office.
Support with quality matters for disposition of product returns.
Assist during FDA inspections and local regulatory inspections at Strides’ US corporate office.
Job-Specific Requirements
Excellent verbal and written communication skills are necessary.
With supervision and direction, effectively prioritizes competing tasks in a fast-paced and dynamic environment.
Motivated, results driven with attention to detail, accuracy and clarity.
Qualifications
BS degree in Pharmacy, Chemistry, Biology or Microbiology is preferred. 1-2 years of Quality Assurance or related pharmaceutical industry experience is preferred. Recent graduates will be considered for this role.

Job Tags

Contract work, Local area,

Similar Jobs

MRINetwork Jobs

Senior Electrical Engineer Solar + Storage Job at MRINetwork Jobs

...Senior Electrical Engineer Solar + Storage Our client is a leading renewable energy engineering firm specializing in commercial and industrial (C&I), PV+ESS, and microgrid project design, engineering, and consulting. They provide expert services to electrical contractors...

Delectable Trading

Warehouse Packer - Fulfillment Center Job at Delectable Trading

...Packers. In this pivotal role, you will be responsible for accurately packing and preparing customer orders for shipment, ensuring that our... ...of our successful team. Responsibilities Accurately pick and pack products according to order specifications. Ensure...

Kaiser Permanente

Ward Clerk Transcriber Per Diem Night Shift Job at Kaiser Permanente

...May support Environmental Services in the data entry into the ADT system the status of clean... ...available for report at beginning of assigned shift.+ Minimizes personal phone call time.+... ...TITLE: Ward Clerk Transcriber Per Diem Night ShiftLOCATION: Irvine, California...

The Zadera Agency

Sales Representative Remote Job at The Zadera Agency

...sell with our qualified clients. This position is 100% remote / work from home. We have high caliber training sessions on products for our... ...Training with Upline Qualifications: Desire for Continuous Self Growth Ability to build rapport with clients Strong...

vTech Solution

Critical Care Nurse Job at vTech Solution

Job Summary: This position is for a Critical Care Registered Nurse in a float pool capacity, rotating between ICU and PCU units on a 4-week... ...Nursing (ASN). Preferred Skills & Certifications: - Previous travel nursing experience. - Bachelor of Science in Nursing (BSN...

Quality Assurance (QA) Associate Job at Strides, East Brunswick, NJ

RmUrOHpaZStMMHhJOWRVQzZsbHFaRzFVbXc9PQ==