Quality Assurance Specialist

SCOPE OF POSITION

Assure that all quality products and processes by establishing and enforcing quality standards. Responsibilities of the Quality Assurance Specialist include managing all quality related investigation programs. Ensure Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP) including addressing customer and regulatory audits.

PRIMARY RESPONSIBILITIES

· Perform Annual Internal Quality Audit (IQA).

· Perform Annual Retention Sample Review.

· Perform Mock Recall every two years.

· Perform Trend Analysis for Quality Assurance (QA) Department.

· Perform onsite supplier/vendor audit and generate summary report.

· Perform risk assessments on all investigations (NCR, DR, and GI) and issue CAPA Report numbers to responsible department.

· Perform Return Goods investigation and disposition the products based on investigation findings.

· File Adverse Event Report (AER) and Medical Device Report (MDR) with FDA.

· File Drug Establishments Registration documents to FDA.

· Address regulatory (FDA) and customer audit.

· Interpret and prepared appropriate documentation for FDA drug / device audits and customer audits.

· Review Incident Reports (IR) from all departments and issue investigation as necessary.

· Perform final reviews on all calibration reports are within specification and signed for compliance.

· Perform batch record reviews (filling, labeling and packaging) to ensure GDP and GMP procedure compliance.

· Issue commodity numbers for various in-process materials.

· Perform Change Controls for various Quality Assurance (QA) and Quality Control (QC) standard operating procedures (SOP’s).

· Responsible for quarantine/release of quarantined products.

· Investigate customer complaints and inquiries and properly document findings.

· Responsible to perform final review on all sterile, non-sterile components and in-process materials and release for manufacturing.

· Supervise Quality Control Inspectors.

· Perform annual current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) training.

· Responsible for approving a new vendor/supplier and maintain Approved Supplier List.

· Manage all investigations program and issue investigation number to responsible department.

· Verify all CAPA issued due to investigations and recommendation from the Management.

· Review monthly inspection reports from all departments.

· Helps prepare / review documents for Annual Product Review (APR).

· Supervise Quality Assurance Assistant.

· Review Code of Federal Regulation (CFR) Title 21 Part 210, 211 and 820 to make sure company standard operating procedure is in compliance.

· Perform final review of differential pressure for the cleanrooms.

· Oversee and maintain retention sample room and review temperature logs.

· Communicate quality related customer inquiries relating to the products.

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

· Complies and adheres to existing and new regulations.

· Complies with all company policies and procedures.

· Must be a team player and customer / results oriented.

· Comply with all company safety policies and procedures to ensure a safe and healthy environment.

QUALIFICATIONS

· Pharmaceutical experience is highly desired and will be given precedence.

· Proficient in Microsoft Excel, Microsoft Word, and File Maker Pro for data management.

· University degree in compliance science or closely related field.

MINIMUM REQUIREMENTS

Preference: Normally receives no instruction on routine work and general instructions on new assignments. Strong verbal communication, proficient in technical writing, and excellent interpersonal skills are required.

Job Type: Full-time

Pay: $68,640.00 - $70,000.00 per year

Benefits:

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

Work Location: In person

Salary : $68,640 - $70,000