Location: Kannapolis,NC, USA
Position Details:
· Contract Duration: 6 months, with potential for extension or permanent placement.
· Work Schedule: 40 hours per week, starting in January.
· Pay Rate: $28 - $30 an hour
· Work Environment: Sole chemist in a start-up environment, working in a collaborative lab space requiring independence and initiative.
· Growth Potential: Opportunity to grow within the company and contribute to the development of new processes and systems.
· Interview Process: Two-stage interview process for quick decision-making.
Key Responsibilities:
Independent Laboratory Management:
o Operate as the sole QC chemist at the NCRC location, managing the QC lab independently.
o Maintain the lab in accordance with GLP standards, ensuring all equipment, including ICP-MS (Inductively Coupled Plasma Mass Spectrometry) instruments, is calibrated and qualified.
o Handle inventory and ensure the availability of materials and reagents for testing.
Quality Control Testing:
o Perform QC testing for medical device combination products, adhering to established protocols and SOPs.
o Operate ICT NS instruments to ensure accuracy and reliability in results.
o Conduct stability, in-process, and final product testing to meet regulatory requirements.
o Perform wet chemistry analyses as required.
Documentation and Compliance:
o Record all test results and findings with precision, following GLP guidelines and company standards.
o Draft, review, and revise Standard Operating Procedures (SOPs) to ensure consistent lab practices.
o Assist in preparing reports and summaries for internal and regulatory review.
o Support audit and inspection readiness by maintaining meticulous records.
Proactive Contribution:
o Take initiative in problem-solving and ensuring deadlines are met.
o Be ready to step up and take ownership of challenges as they arise.
Qualifications:
Education:
o Associate's degree in a scientific field (e.g., Chemistry, Biochemistry, or Pharmaceutical Sciences) or a Bachelor's degree preferred.
·
Experience:
o Minimum of 2 years of experience in a GLP-regulated laboratory.
o Hands-on experience with ICP-MS instrumentation, ICT NS instruments, and wet chemistry techniques is required.
o Previous experience with medical device combination product testing is a plus.
Skills:
o Strong attention to detail and ability to work independently with minimal supervision.
o Excellent organizational skills and the ability to manage multiple priorities effectively.
o Proficiency in following GLP protocols and maintaining meticulous documentation.
Attributes:
o Hardworking, reliable, and highly trustworthy.
o Passionate about science and quality control.
o A self-starter who thrives in a fast-paced start-up environment and isn't afraid to take initiative.