Lab Assistant (Stability Coordinator), Pharmaceutical Manufacturing

Smart Media; Chantilly (VA); On-site; USD 50,000 - 70,000; Full time

Job summary

Smart Media, located in Chantilly, Virginia, is seeking a Quality Control professional to manage their stability program. This role involves data management, compliance with stability SOPs, and reviews of the stability program. Candidates should have a BS or MS in a scientific field and 0-2 years of relevant experience. Additional experience in GMP quality control or pharmaceutical manufacturing is preferred. Strong analytical skills and the ability to work in a team are essential. The position offers opportunities to work in a high-quality pharmaceutical environment.

Qualifications

• 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 FDA guidelines on Stability requirements is a plus.

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.

Skills

Data analysis

Quality Control

Excellent computer skills

Communication skills

Team collaboration

Education

BS or MS in Chemistry, Pharmacy, Biochemistry, Biology or Biotechnology

Tools

HPLC

GC

FT-IR

Job description

Company Overview

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.
• Assure that stability samples are disposed of according to GMP guidelines.
• Assist in preparing and maintaining batch records, certificate of analysis, maintain/control and file records of raw material specification and finished product specification.
• Ensure that stability chambers and monitoring system are performing within set requirements.
• Use professional skills and concepts to solve a variety of often complex situations, make clear and concise decisions of vast importance within limited periods of time, and 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 communication 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.

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.