Job Description

Outstanding biotech company seeks an experienced Compliance Associate II to join their team! In this role you will be responsible for performing various activities pertaining to assuring compliance with applicable regulatory requirements, such as assisting with the internal, customer, and vendor audit programs. Responsibilities: • Assists with internal audit program by conducting audits, writing audit reports, evaluating responses to audit observations, and verifying closure of corrective actions. • Assists with vendor quality program by sending/receiving non-critical vendor questionnaires, tracking vendor quality issues, and verifying closure of corrective actions. • Assists with customer audit program by retrieving and preparing documentation, communicating and coordinating with internal SMEs, and tracking completion of corrective actions. • Assists with regulatory inspection process by retrieving requested documentation. • Assists with the vendor complaint program through complaint intake, data entry, vendor communication, and verifying closure of corrective actions • Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Requirements: • Bachelor’s degree in Life Sciences discipline or equivalent preferred. • Minimum of two to four (2-4) years of experience in a GMP experience. • Understanding and proven application of good documentation practices (GDP). • Basic understanding of regulatory requirements related to aseptic drug product manufacturing and testing. • Good understanding of internal requirements related to quality management systems, risk management, and supplier qualification. • Developing communication and team collaboration skills. • Detail-oriented with strong organizational skills. • Proficient with Microsoft Office applications. Qualified candidates, please submit your resume for immediate consideration.

Company Description

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