Analytical QA Specialist

Strides Pharma Inc•Chestnut Ridge, NY

About The Position

We are seeking a highly skilled and detail-oriented Analytical Quality Assurance Specialist to join our team in ensuring the accuracy, compliance, and overall quality of raw materials and finished products in a pharmaceutical environment. The ideal candidate will possess significant experience in material/product review, release processes, and laboratory functions. This role requires in-depth knowledge of government regulations, industry standards, and internal policies to support the company's commitment to product safety and quality. The Analytical Quality Assurance Specialist will work closely with cross-functional teams to prioritize, assess, and resolve issues related to raw materials, product testing, and quality systems.

Requirements

Minimum 7-10 years of experience in the pharmaceutical industry related to material/product review, release, and laboratory functions.
Expertise in reviewing and managing GMP documents, raw material and product testing, and quality systems.
Proficiency with laboratory systems and software tools such as LIMS, SAP, and EMPOWER.
Strong understanding of regulatory guidelines, including FDA, EMA, and ICH, as well as industry standards and best practices.
Associate or Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related scientific field.

Responsibilities

Review raw material and finished product testing result records, including Certificates of Analysis (C of A), Certificates of Conformance (C of C), and laboratory reports to confirm accuracy.
Determine the acceptability of materials/products for release based on compliance with specifications and testing results.
Perform ERP transactions for the release, hold, or rejection of raw materials and finished products.
Prioritize raw material review and release based on production scheduling requirements.
Review and approve GMP documents such as change control documentation, batch records, method validation protocols and reports, stability protocols and reports, and analytical method transfer protocols and reports.
Ensure that all documents adhere to regulatory requirements and internal quality standards.
Make informed decisions based on a thorough understanding of FDA regulations, industry guidelines, risk-based assessments, and internal policies to ensure compliance across all materials/products.
Review and assess Change Control requests, Out of Specification (OOS) investigations, Corrective and Preventive Actions (CAPAs), and other Quality Management System (QMS) events.
Take appropriate actions to resolve compliance issues and escalate to management when necessary.
Identify potential errors or compliance risks and take necessary actions to mitigate impact, including placing products on quality hold or rejection if needed.
Work with the management team to communicate issues, propose resolutions, and ensure the integrity of the quality system.
Ensure all QMS events are complete and closed prior to raw material or finished product release for use.
Collaborate with internal departments to ensure smooth operations and compliance in product release processes.
Provide timely feedback and reports to stakeholders on quality assurance activities, trends, and issues.