QC Scientist Position Available In Edgecombe, North Carolina

QC Scientist
locations
United States – North Carolina – Rocky Mount
time type
Full time
posted on
Posted 4 Days Ago
job requisition id
4934480
Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the needs of those we serve. By being part of our team, you play a crucial role in maintaining this high standard and making a difference in the lives of patients.
What You Will Achieve
In this role, you will:
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.
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.
Here Is What You Need (Minimum 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.)
Bonus Points If You Have (Preferred Requirements)
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
Physical/Mental Requirements
Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis.
Non-Standard Work Schedule, Travel or Environment Requirements
Schedule is 1st shift, Monday – Friday. Must be able to work on weekend, off shifts and holiday as business demands. Travel