QC Scientist

QC Scientist I

The QC Scientist I performs bench-level analytical testing to support the development and release of multisource pharmaceutical products. This role focuses on chemical and physical analyses, including sample preparation, wet chemistry, standard weighing, and dilutions, with progressive training on HPLC and GC techniques. The scientist provides analytical support for registration material release, regulatory submissions, and method validation and transfer activities while working across both Oral Dose Solids and Nasals departments in a fast-paced, team-oriented environment.

Responsibilities

• Perform routine bench testing, including sample preparation, wet chemistry, standard weighing, and dilutions in support of product development and quality control activities.
• Conduct chemical and physical analyses to support the development of manufacturable multisource pharmaceutical products.
• Provide analytical support for the release of registration materials in support of regulatory submissions.
• Assist with analytical method validation and method transfer activities as directed.
• Execute assigned analytical tasks to support product development, registration lot release, and pre- and post-regulatory submission activities within defined timelines.
• Work in compliance with cGXP requirements and adhere to company practices, procedures, and quality standards.
• Follow written work instructions, standard operating procedures (SOPs), and company practices for all analytical activities.
• Document analytical activities and results accurately, in a timely manner, and with a right-first-time mindset to maintain data integrity.
• Follow written analytical procedures and ensure consistent execution of established methods.
• Identify execution challenges related to analytical methods and support troubleshooting activities to resolve issues.
• Train and perform analytical work in both the Oral Dose Solids and Nasals departments as needed.
• Collaborate effectively with team members in both quality and manufacturing areas to accomplish assigned tasks.
• Manage multiple tasks in a fast-paced environment while maintaining high quality and compliance standards.
• Communicate clearly and professionally in writing and verbally to report results, issues, and progress to supervisors and colleagues.
• Work under supervision while applying scientific judgment and professional competency to analytical tasks and problem-solving.

Essential Skills

• Bachelor's degree in a science field is required.
• Strong preference for a Bachelor's degree in Chemistry or Biochemistry.
• Candidates with degrees in Biology, Microbiology, Physics, Environmental Science, or Pharmaceutical Science may be considered with strong chemistry laboratory experience.
• Demonstrated prior laboratory experience, which may come from academic coursework or research.
• Strongly preferred experience in a laboratory setting outside of academia.
• Hands-on experience with sample preparation and dilutions.
• Experience performing wet chemistry techniques and chemical testing.
• Foundational knowledge of chemistry and biochemistry principles applied in a laboratory environment.
• Ability to work effectively in a team environment to accomplish shared goals and assigned tasks.
• Ability to manage multiple tasks in a fast-paced environment while maintaining attention to detail.
• Good written and verbal communication skills for documenting work and collaborating with colleagues.
• Ability to work under supervision while using scientific judgment and professional competency.
• Commitment to following cGXP requirements, SOPs, and established analytical procedures.

Additional Skills & Qualifications

• Exposure to or interest in learning HPLC and GC techniques, with on-the-job training provided over time.
• Experience in quality control or pharmaceutical laboratory environments is an advantage.
• Familiarity with analytical method validation and method transfer activities is beneficial.
• Experience working in both academic and industrial laboratory settings is valued.
• Strong organizational skills and a right-first-time approach to documentation and data recording.
• Ability to identify and communicate analytical method execution challenges and contribute to troubleshooting efforts.

Work Environment

This role operates in a fast-paced pharmaceutical manufacturing and quality environment. The QC Scientist I spends significant time in the quality control laboratory performing bench testing and will also occasionally work in the manufacturing area as needed. The position involves working in both the Oral Dose Solids and Nasals departments, providing exposure to a variety of dosage forms and analytical techniques.

Work is performed under cGXP conditions with strict adherence to SOPs, data integrity standards, and safety procedures. The schedule is primarily a second-shift role, Monday through Friday from approximately 3:00 p.m. to 11:30 p.m., with potential flexibility to work four 10-hour shifts depending on business needs. The environment emphasizes internal growth,…