This position is primarily responsible for coordinating and directing quality assurance programs and reviewing, preparation/maintenance of SOPs, calibration and other controlled document to ensure accuracy, completeness, and adherence to establishment standards by performing the following duties.
Four year college degree or master degree; and two to three years related experience and/or training; or equivalent combination of education and experience.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Ensures compliance with cGMP, Company SOPs and FDA requirements during all phase of operations.
Prepares of SOP's to help Implement Quality System at all levels within the organization
Maintains the records for calibration on process equipment, calibration on QA data logger and calibration on engineering equipment.
Maintains and oversees documentation control of all regulated documents.
Prepares and maintains record for change control, planned or unplanned deviation, customer complaint investigation report, mock recall, annual GMP training.
Generates regulated documents in line with the cGMP for Dietary Supplement 21 CFR 111.
Completes quality assurance operational requirements by scheduling or co-ordination with other departments.
Prepares and maintains record of testing requisition for water analysis.
Updates and maintains records including training, SOPs, Validation and Calibration.
Assesses incoming complaints and escalate issues that require QA Manager's immediate attention.
Executes and participate in internal and external audits.
Ensures that all Quality Systems, including CAPA, Complaint Handling, Deviations, Nonconforming Product, and Internal Auditing comply with FDA.
Follows up any task assigned by the QA Manager.
Our jobs come with great benefits - including healthcare and ways to save for the future-
Healthcare (medical, dental, vision, prescription drugs)
Network of Support (health & well-being on and off the job)
401(k) savings plan
Paid Time Off (PTO)
Basic life insurance
Company-paid Short-Term and Long-Term Disability
On-the-job training and skills development
Employee Assistance Program