Quality Assurance Investigations Analyst

2 weeks ago

Albuquerque, New Mexico, United States curiate Full time

Position Overview:

As a vital member of the Curia team, the Quality Assurance Investigations Analyst plays a crucial role in ensuring the integrity of our pharmaceutical and biotechnology services. This position is based in Albuquerque, New Mexico, and is essential for maintaining high standards in quality assurance across our operations.

Key Responsibilities:

  • Lead and provide subject matter expertise for Good Manufacturing Practice (GMP) investigations.
  • Collaborate with Quality and Operations teams to ensure facilities and processes are always prepared for regulatory inspections.
  • Guarantee timely and accurate execution of production activities in partnership with Quality and Operations.
  • Oversee commissioning and qualification activities as per the validation lifecycle.
  • Conduct audits of Quality Assurance processes to identify improvement opportunities in training and data management.
  • Review GMP documentation for compliance with company and contractor standards.
  • Support the investigation of product complaints, deviations, and failures.
  • Act as the analytical and technical expert in Quality Assurance.
  • Contribute to Curia's core values of Quality, Timeliness, Communication, and Profitability.
  • Review and release batch records for manufacturing and packaging.
  • Lead investigations and resolutions of significant quality issues and customer complaints.
  • Perform root cause analysis and implement corrective actions for process-related issues.
  • Recommend updates to Standard Operating Procedures (SOPs) as necessary.
  • Assist the Compliance department during inspections by regulatory agencies and audits.
  • Maintain up-to-date knowledge of relevant quality assurance codes and standards.
  • Drive continuous improvement initiatives to enhance the quality system.
  • Collaborate with Engineering and Operations to ensure new products are transitioned to production following approved protocols.
  • Participate in site or global projects aimed at quality enhancement.
  • Establish and maintain effective working relationships with various departments including Clinical Supply Chain Management, Production, and Quality Assurance.

Qualifications:

A Bachelor’s Degree in Science, Chemistry, or Biology is required, along with less than three years of experience in quality assurance or regulatory roles within the pharmaceutical sector. A solid understanding of laboratory, manufacturing, packaging, and compliance requirements is essential.

Skills:

  • Proficient in reading and interpreting professional literature and regulatory guidelines.
  • Strong written and verbal communication skills, with the ability to develop and document procedures independently.
  • Mathematical aptitude for calculations related to concentrations, percentages, and volumes.
  • Problem-solving skills to address various challenges using practical experience.

Additional Requirements:

  • Successful completion of a background check and drug screening.
  • Ability to perform physical tasks associated with the role, including sitting, standing, and lifting light weights.

This job description is intended to provide a general overview of the position and does not encompass all duties that may be assigned. Curia is an Equal Opportunity Employer, committed to diversity and inclusion in the workplace.

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