Quality Analyst

About the position

SourceAbled is seeking candidates for an exciting opportunity with a biopharmaceutical company in Frederick, MD for the position of Quality Analyst. The role involves performing selected quality control bioassay testing activities, conducting finished product and stability testing according to standard operating procedures, and completing appropriate documentation supporting testing procedures. This includes data capture forms, equipment logbooks, and inventory forms. The Quality Analyst will enter data evaluated for compliance to specifications and report abnormalities, maintain laboratory equipment, and ensure supply levels are adequate to support performance of assigned duties. The candidate must read, understand, and follow SOPs and comply with cGMPs, applying critical thought to problem-solving and adhering to company safety procedures and guidelines. Training must be maintained at 95% completion on time, with 100% completed prior to performing any related analysis.

Responsibilities

• Perform quality control bioassay testing activities.
• Conduct finished product and stability testing according to standard operating procedures.
• Complete documentation supporting testing procedures, including data capture forms, equipment logbooks, and inventory forms.
• Enter data evaluated for compliance to specifications and report abnormalities.
• Maintain laboratory equipment according to standard operating procedures.
• Maintain supply levels to support performance of assigned duties.
• Read, understand, and follow SOPs and comply with cGMPs.
• Apply critical thought to solving problems.
• Adhere to company safety procedures and guidelines.
• Maintain training at 95% completion on time, with 100% completed prior to performing any related analysis.

Requirements

• BS/MS in biological or chemical science (chemistry, or biochemistry, etc.).
• 0-5 years of experience preferably in the pharmaceutical industry.
• Ability to plan and carry out laboratory operations efficiently and effectively.
• Ability to maintain accurate records of all experiments and data.
• Critical thinking and attention to detail.
• Must be a team player and customer-oriented.
• Experience in QC or GMP is a plus.
• COVID vaccination required.

Nice-to-haves

• Experience with cell culture or bioassay.
• Experience with GMP or GLP.