Senior Quality Control Analyst chez VIVEX BIOLOGICS INC

Description

The Senior Quality Control Analyst is responsible for supporting and managing tests of incoming raw materials, in-process samples, and final product samples. Analyze and approve testing data ensuring internal specifications are in accordance with standard operating procedures requirements. Write, review and approves procedures, reports, and investigations. Supports management in leading and mentoring QC personnel. Develops and implement procedures, protocols, and lead the optimization of quality control processes and programs. Performs all functions in accordance with standard operating procedures, all applicable federal and state regulatory and accrediting standards requirements.

Requirements

Responsibilities

• Provide  support as needed by executing testing and inspections pertaining to QC laboratory.
• Lead analysts on routine tasks ensuring the laboratory runs efficiently and execution is performed according to internal      procedures.
• Coordinate and schedule microbiology team responsibilities and tasks.
• Ensure laboratory testing is performed in accordance with USP, FDA, and AATB requirements.
• Identify opportunities for improvements and proactively make recommendations for changes and process improvements.
• Lead cross functional investigations in collaboration with personnel from different departments.
• Provides direction as a subject matter expert in QC related methods and programs.
• Approves test results according to internal standard procedures to ensure proper management, tracking, and disposition      of materials and products. 
• Participate in release management meetings and provide overall testing updates on the assigned projects.
• Review, tracks, and close non conformances (NCR), deviations, and change controls to ensure QC follows internal quality system requirements. 
• Owns QC investigations, including determining root cause of failures, immediate impact and initial containments and developing   and implementing corrective actions. 
• Develop and execute qualification and validation protocols related to QC.
• Supports management in leading audits and inspections, accreditation, and licensing activities as needed.
• Compiles, interprets, and documents data from testing to evaluate final product compliance to internal requirements and industry   standards.
• Perform training of new employees.
• Perform other duties as required.

Qualifications

Education/Experience: Bachelor’s degree in science with at least 5 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). 

Associate’s degree in science with at least 7 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). 

Skills: Excellent interpersonal, verbal, and written communication skills required. 

Must demonstrate excellent organizational and record-keeping skills. 

Must be detail oriented with the ability to multi-task in a high-pressure environment. 

Proficient in Microsoft Office. 

Working conditions

Fast pace, office, and lab-oriented work environments. Able to work evenings and weekends as required.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit or stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

Direct reports

No direct reports.

Nothing in this job description restricts management’s right to assign or reassign duties and 

responsibilities to this job any time.