QC Scientist

QC Scientist

Requirements

• Applicant must have a bachelor’s degree with 3+ years OR a master’s with 0+ years of experience.
• Demonstrated experience in manufacturing, quality, or engineering within the biotech or pharmaceutical industry
• Solid understanding of aseptic laboratory techniques and quality systems
• Ability to establish strong relationships within business lines
• Excellent written and verbal communication and interpersonal skills
• Proficiency in laboratory information management systems and data analysis software
• Strong problem-solving skills and attention to detail
• Experienced with analytical lab equipment (FTIR, Microscopes, etc.)

Responsibilities

• Contribute to achievement of goals at the work group/ project team level as a full team participant.
• Perform tasks associated with maintaining {Current} Good Manufacturing Practices {part of GxP} compliant Quality Control and Stability laboratories.
• Represent Quality Control Analytical in cross functional and site product meetings.
• Interpret data and make recommendations and reach decisions based on data and management input.
• Apply existing techniques and procedures, with recommendations, and implementation of modifications for improved efficiency, or devise and develop new microbiological Reporting issues to management and participating in issue resolution.
• Train junior colleagues, develop training plans and oversee training activities for groups.
• Provide subject matter expertise for standard operating procedures and quality standards content, as well as providing gap analysis to ensure that the microbiological finished product laboratories stay compliant with all regulatory requirements.
• Support change controls, investigations and other technical documents.
• Participate in regulatory filing writing in sections related to analytical method and stability testing.
• Conduct and review non-conformance investigations related to manufacturing and stability.
• Review and approval of data in Laboratory Information Management System for lot release.

Preferred Qualifications

• Experience in Quality Operations
• Familiarity with regulatory requirements and compliance standards
• Ability to work independently and as part of a team
• Strong organizational and time management skills
• Ability to adapt to changing priorities and work in a fast-paced environment
• Experience defending laboratory practices in regulatory audit.
• Working knowledge of organic chemistry, including degradation mechanisms of pharmaceutical active ingredients and pharmaceutical products
• Use of microscopes (i.e Scanning Electron Microscope), Raman Technology (i.e. Hound) and/or FTIRs
• Particulate/Particle Identification expertise