The Quality Assurance (QA) Department at T&T Scientific is responsible to develop and implement a quality system fully compliance with regulatory agencies; the QA team monitors, inspects, establish quality standards, and continuously improves the quality measures and establishing at the company. This department on daily basis writes, revises, and reviews SOPs and controlled forms, and related documents to ensure best practices and current operations. The QA staff are responsible for the quality of all in-process and finished products, ensuring compliance with all applicable regulations and client's specifications; the QA team will also be ensuring the compliance of day-to-day operation in manufacturing and quality control with GMP, FDA, OSHA and all other regulatory requirements in accordance with company policy.
- Establishing a Pharmaceutical Development and Manufacturing (CDMO) Quality System Compliance with FDA Guidelines and Regulations to Be Followed by Different Departments at the Company.
- Continuously Learning about and Improving Knowledge of Standard Operating Procedures (SOPs) Latest Regulations and Guidelines for Assay and Testing Procedures, FDA Regulations, and Current Good Manufacturing Practices (cGMPs).
- Internally Audit the Quality System Implemented within the Organization
- Establish Procedures and Specifications for Standards within the Organization.
- Review All Processes that Follows cGMP Standards to Approve or Reject; and Investigate Any Non-conformance Event at the Organization.
- Remaining Independent from Manufacturing, and Quality Control Team Members.
Skills: Attention to Details, Reading and Writing, Communication, Comprehension, Decision Making, Risk Assessment, Organization, and Creativity.
Experience: Regulatory Affairs, Knowledge, and Experience of Reading, Comprehending, and Implementing the FDA and Good Manufacturing Practices Guidelines.
Education: There is No Required Education and Degree for Any Position at T&T Scientific.
- Health Insurance: 90% Coverage for Employees and Their First Family with a Wide Range of Plans Company Insurance Plans
- 401K Retirement Plan: 100% Company Matching Contribution on the First 3% of Pay that Employee Contributes; 50% Company Matching Contribution on the Next 2% of Pay that Employee Contributes (Company Performance Based Additional Annual Company Retirement Contribution).
- Every Weekdays Free Lunch at the Corporate Office (Monday-Friday)
- Relocation Fees Coverage: 100% Coverage for Relocation Upto $8,000 Reimbursement
- Paid Time Off (PTO): Most Competitive Number of Paid Time Off per Year with Maximum Possible Rollover from Year to Year
- Cash Bonus: Over the Top and Competitive Salary, Plus Cash and Raise Based Bonuses (Guaranteed and Performance-Based) on Candidate's Criteria Maybe Added to Offer. Additional Upto 5% Raise of Salary Compensations.
- Special Rewarding Employee Appreciation Programs (Terms and Conditions Are Applied).
- Paid Parental Leave (Terms and Conditions Are Applied).