Audit Manager at THE RITEDOSE CORPORATION

, South Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Apr, 26

Salary

95000.0

Posted On

10 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Internal Audits, Supplier Quality Management, Regulatory Audits, cGMP, 21CFR, Quality Assurance, FDA Audits, Corrective Actions, Communication Skills, Interpersonal Skills, Mentoring, Database Software, Word Processing, Quality Alerts, Trending Analysis, Regulatory Compliance

Industry

Pharmaceutical Manufacturing

Description

Job Details Job Location: The Ritedose Corporation - Columbia, SC 29203 Salary Range: $85,000.00 - $95,000.00 Salary/year The Audit Manager is responsible for the internal audit program, supplier quality management and coordination/execution of customer and regulatory audits. Responsibilities: Ensure execution of internal audits according to the Internal Audit Master Plan Track the execution of corrective action implementation of audit findings Provide oversight to supplier quality management process Conduct supplier audits including on-site inspections when required Maintain a history of audits performed and schedule repeat audits as required Coordinate and manage supplier quality alerts Coordinate and participate in regulatory and customer audits Perform trending of audit findings and identify opportunities for improvement Maintain current knowledge of regulations and guidance documents Manage and mentor audit personnel Qualifications: Four year college degree in Pharmacy, Chemistry, Biology or related field 5-10 years’ experience in the pharmaceutical industry with a quality background Thorough knowledge of cGMP/ 21CFR with related experience in regulatory and compliance ASQ Certified Quality Auditor required Experience with FDA audits Proficient with current word processing and database software Strong interpersonal/group skills with ability to motivate and direct others Strong communication skills, verbal and written Qualifications Qualifications: Four year college degree in Pharmacy, Chemistry, Biology or related field 5-10 years’ experience in the pharmaceutical industry with a quality background Thorough knowledge of cGMP/ 21CFR with related experience in regulatory and compliance ASQ Certified Quality Auditor required Experience with FDA audits Proficient with current word processing and database software Strong interpersonal/group skills with ability to motivate and direct others Strong communication skills, verbal and written

Responsibilities

The Audit Manager is responsible for overseeing the internal audit program and managing supplier quality processes. This includes conducting audits, tracking corrective actions, and coordinating regulatory and customer audits.