About this role
Associate QC Chemist
• Perform and document routine analytical, biochemical, and non-compendial testing of in-process, release, and stability samples in accordance with approved SOPs, test methods, and cGMP requirements.
• Operate, calibrate, maintain, and troubleshoot QC laboratory instruments and equipment in a compliant and efficient manner.
• Apply knowledge of cGMP, FDA regulations (21 CFR), ICH guidelines, and other applicable regulatory requirements to ensure laboratory compliance.
• Review laboratory procedures and identify continuous improvement opportunities to enhance compliance, efficiency, and data integrity.
• Author, revise, and maintain laboratory SOPs, protocols, and controlled documents as required.
• Assist with laboratory investigations, deviation assessments, OOS/OOT investigations, root cause analyses, and analytical method troubleshooting.
• Support critical reagent qualification and requalification activities.
• Participate in analytical method qualification, validation, verification, transfer, and compendial method implementation activities.
• Maintain accurate, complete, and contemporaneous documentation in accordance with ALCOA+ and data integrity principles.
• Adhere to all laboratory safety requirements and actively support a safe working environment.
• Serve as a trained Self-Inspection Auditor and participate in at least 25% of departmental self-inspection activities to support audit readiness and continuous compliance.
Qualifications
• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• 1-3 years of experience in a cGMP pharmaceutical, biotechnology, or biologics laboratory environment.
• Working knowledge of analytical and biochemical testing techniques and laboratory instrumentation.
• Familiarity with FDA cGMP regulations, 21 CFR Part 210/211, data integrity requirements, and laboratory compliance practices.
• Strong technical writing, problem-solving, and organizational skills.
• Ability to work independently as well as collaboratively in a fast-paced QC laboratory environment.
The anticipated salary range for this position in Maryland is $67,072 to $89,430 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Benefits: · 13 paid holidays · Vacation time · 401K match · Medical, dental and vision benefits effective day one of employment