Quality Control Specialist Data Integrity

Quality Control Specialist - Data Integrity in Springfield, MO

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture.

The Quality Control department is responsible for support of the manufacturing department and external customers. The routine functions of the laboratory are testing of raw materials, in-process, end product, and stability samples. The department also tests plant water for production.  

The Quality Control Specialist - Data Integrity should incorporate sound judgement, critical thinking, and cGMP principles to ensure the integrity of the data meet acceptable quality standards. The Quality Control Specialist - Data Integrity will provide appropriate guidance to analysts, supervisors, and quality personnel to promote compliance for Curia and our customers.  

Responsibilities

• Apply technical and regulatory knowledge and judgement to review experimental data for compliance with internal SOPs and quality standards with minimal supervision 
• Identify data trends, atypical results and communicate issues for potential investigation to management, as necessary.
• Communicate with analytical scientists, supervisors, and management on technical issues. 
• Work with management on investigations, audit responses, corrective/preventative actions, and process improvements
• Author, review and/or approve SOPs, forms, protocols, or other documentation, as needed
• Provide support to ensure QC lab maintains compliance in areas including:
  - Reference Standards
  - Stability
  - Instrument Calibration
  - Data Integrity
• Work independently to organize priorities, tasks, and duties to meet customer and business needs.
• Actively participate in training and development to continuously increase knowledge of Curia policy and procedures, regulatory standards and requirements, software systems and analytical instrumentation 
• May train other staff on laboratory compliance topics

Qualifications

Required:

The following knowledge and proficiency skills are required for this position:

• Bachelor's degree with major in Natural Science or Pharmacy and minimum 2 years of experience in industrial laboratory environment or Associates degree and minimum 4 years of experience in an industrial laboratory environment
• Good knowledge of analytical chemistry including wet chemistry and instrumental methods of analysis.
• Strong computer and math skills.
• Well-developed oral and written communication skills.
• Ability to work with changing priorities in a high-pressure environment.

Preferred:

• Experience with Empower 3 CDS
• Experience with GDP, GLP, and GMP requirements
• Statistical Analysis Experience

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

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