Quality Assurance Specialist II (QC Compliance)

The job will encompass the following responsibilities in general:

· Review all QC analytical test data packets for raw materials, API, drug product and consumables. Write certificates of analysis. Execute batch release in compliance with cGMP internal SOPs and Specifications as needed.

· Generate, Review and approve Corrective and Preventive Action reports (CAPA), change control and laboratory quality events pertaining to QA, QC and R&D activities. Drive to ensure timely closure.

· Write, Review, Support, escalate and drive to timely closure OOS (Out of Specifications) events. Ensures Investigations are robust and thorough prior to approval and closure.

· Responsible to discuss data interpretation with individual analysts and elevate, if necessary, to determine data disposition.

· Facilitates laboratory data or documentation corrections with analysts to ensure accuracy.

· Create, maintain and approve relevant SOPs for QA and QC instruments, analysis, analyst qualifications, data review and data integrity and reporting as needed.

· Drive implementation and review of Data integrity, Data review controls and electronic data audit trails to ensure data integrity.

· Responsible for Stability Program Management for commercial and R&D products in compliance with internal SOPs and Regulatory guidelines.

· Review and approve protocols and reports for Method Validation, Method Transfer and instrument qualification in compliance with regulatory and internal guidelines.

· Ensure all QC personnel are appropriately trained.

· Maintain Trend analysis.

· Responsible for ensuring proper handling and control of working standards, retain samples, reject material and test samples returned to QA after QC analysis.

· Continuous improvement of laboratory GMP compliance and implement solutions where deficiencies are found.

· Support Inspection Readiness at site in coordination with Site QA and participate in regulatory agency and customer audits.

· Responsible for compiling data and analysis of data for QC and QA activities in the Annual Product Review.

· Be flexible on work hours & weekend work periodically to support critical schedule requirements

· Execute additional projects as needed.

Background And Experience:

- Bachelors Degree in Chemistry or Biology

- Minimum 4 years experience working in quality control or quality assurance

- Sound analytical skills

- Sound math skills

- Sound communication skills

- Understanding of statistics

Job Type: Full-time

Pay: $58,000.00 - $68,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Schedule:

• Day shift

Education:

• Bachelor's (Required)

Experience:

• QC Lab: 2 years (Required)
• Data Review: 2 years (Required)
• CGMP: 4 years (Required)
• Pharmaceutical: 4 years (Required)

Location:

• Maryland Heights, MO 63043 (Preferred)

Ability to Commute:

• Maryland Heights, MO 63043 (Required)

Ability to Relocate:

• Maryland Heights, MO 63043: Relocate before starting work (Required)

Willingness to travel:

• 25% (Required)

Work Location: In person

Salary : $58,000 - $68,000