Quality Assurance Manager Tulex Pharmaceuticals Cranbury, NJ Job Details Full-time $90,000 - $120,000 a year 4 days ago Benefits Dental insurance 401(k) Tuition reimbursement Retirement plan Qualifications Staff supervision Bachelor of Science Writing skills Bachelor's degree Quality assurance experience within pharmaceutical industry Training & development Managing product quality assurance teams FDA regulations Pharmaceutical manufacturing facility experience Full Job Description Job Overview We are seeking a highly skilled and detail-oriented Quality Assurance Manager to lead our quality assurance initiatives. As the Quality Assurance Manager, you will oversee the development and execution of testing strategies, ensure adherence to industry standards, and drive continuous improvement in product quality. Requirement B.S. in Chemistry or Life-sciences field with Minimum of 7 Year's quality assurance experience in Pharmaceuticals. Supervisory role for 2 years is necessary. Previous experience with FDA inspections is preferred. ASQ certifications like CQA/CQM is preferred. Must have good work ethics and attitudes. Must have good communication and interpersonal skills. Paying attention to details is required. Duties Responsible for daily QA operations including production, packaging and warehouse and QA documentation. Write, review, update, approve and train SOP's to ensure cGMP compliance, as required. Review and approve raw materials and components and approve quality control documents, including drug products release and stability samples. Ensure thorough and compliant investigations, including Deviations, Root cause analysis and CAPAs. Confirm the timely closures by following up with concerned departments. Supervise the Change control program. Assist in writing, review and approval of Qualification documents (IQ/OQ/PQ). Manage and track employee training matrix and respective training files. Participate in writing the Annual Product Reviews. Conduct qualification audits on vendor / supplier as well as internal audits. Act as a secondary contact for FDA inspections. Train QA employees on job functions, assign the daily tasks, supervise, follow-up and conduct performance reviews for direct reports. Initiate and lead projects for continuous improvements and efficiencies. Coordinate with inter/intra departments to meet the company timelines and resolve issues. Attend required training courses, conferences, meetings, and seminars as necessary. Perform any other activities as required or assigned by management.

Pay:

$90,000.00 - $120,000.00 per year

Benefits:

401(k) Dental insurance Retirement plan Tuition reimbursement

Work Location:

In person