QC Lab Tech (Stability Coordinator) (Pharmaceutical Manufacturing)

Description:

Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and we are currently the 10th fastest growing generic pharma company in the US!

With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.

We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.

Job Summary:

Perform a variety of activities to administer the stability program and manage data generated in support of the company’s quality program.

Essential Responsibilities:

• Comply with the requirements of stability standard operating procedure.
• Data entry and usage of stability software.
• Review stability program annually and recommend revision when necessary.
• Provide stability summary to QC Director upon completion of study.
• Assures that stability samples are disposed of according to GMP guidelines.
• Will assist in preparing and maintaining batch records, certificate of analysis, maintain/control and file records of raw material specification and finished product specification.
• Responsible for ensuring stability chambers and monitoring system are performing within set requirements.
• Employee uses professional skills and concepts to solve a variety of often complex situations. Able to make clear and concise decisions of vast importance in limited period of time. Must be able to perform multiple tasks in the proper sequence to effectively reach desired goals.
  
  

Requirements:

• Minimum Associate’s Degree, Bachelor’s degree preferred in pharmacy, chemistry or related scientific field
• 0-2 years’ experience in Quality control laboratory.
• Knowledge of and ability to work with equipment, supplies, components and technical areas that are utilized in the pharmaceutical industry.
• Knowledge of FDA guidelines on Stability requirements is a plus;
• Must be able to analyze data and work with a high degree of accuracy;
• Organized and able to perform duties in a timely manner;
• Must be flexible and able to handle multiple activities;
• Must have excellent computer skills and verbal and written commutation skills.
• Must be able to work in a team environment; team player.
  
  

Additional Preferred:

• Experience in GMP quality control and/or pharmaceutical manufacturing facility;
• Pharmaceutical stability operations experience
  
  

Physical Conditions

Long periods of sitting, standing, walking, bending, stooping, reaching, and lifting. Will work around powders and other chemicals. Protective eyewear is necessary to wear in the laboratory or manufacturing.

Requirements:

Preferred Knowledge & Skills:

• Strong knowledge of the major analytical techniques: HPLC/UPLC, GC, dissolution, etc. FT-IR, FDA/ICH regulations.
• Solid knowledge of FDA/ICH regulations.
  
  

Required Experience & Education:

• BS or MS in Chemistry, Pharmacy, Biochemistry, Biology or Biotechnology or related field.
• Minimum 2 - 5 years of experience in using analytical instrument techniques including HPLC/GC/FT-IR, UV-Vis, Dissolution Apparatus, Ovens/Auto Titrators/KF Titrator/Particle size analyzers/ Ion-Chromatography.