Senior QC Specialist - Stability Coordinator and Operations

CAMRIS International • Silver Spring, MD

253d

About The Position

We are seeking a Senior Quality Control Specialist - Stability Coordinator and Operations to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects. CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs. Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Requirements

• BA/BS degree in a science field (preferably chemistry, biochemistry, biology, microbiology, or engineering).
• 8 years of experience in a regulated laboratory environment.
• Proficiency in Microsoft Office applications (including Word and Excel) and Laboratory Information Management Systems (LIMS).
• Strong knowledge of aseptic technique, cGMP, cGLP, or FDA regulatory guidelines.
• Expertise in stability studies, analytical techniques, and laboratory equipment.
• Strong communication skills, including technical writing skills and the ability to explain and teach methodologies.
• Ability to manage multiple projects and adapt to changing priorities as needed.
• Must be able to work independently and make data-driven decisions.

Responsibilities

• Lead and manage the Stability Program, ensuring compliance with regulatory guidelines and internal quality standards.
• Author and maintain stability reports for PBF.
• Interact with clients regarding all matters related to the stability program, including plan revisions, coordinating shipments, communicating summary results, etc.
• Perform trend analysis of stability data, identifying potential issues and recommending corrective actions when necessary.
• Provide expertise in stability-related investigations, including deviations, out-of-specification (OOS) results, and failure analyses.
• Participate in SOP drafting, revisions, and development of new assays/programs as needed.
• Oversee the planning, scheduling, and execution of sample analysis for microbiological and analytical testing.
• Supervise and coordinate environmental monitoring (EM) and cleaning validation activities, ensuring compliance with cGMP and company policies.
• Ensure timely receipt, verification, and processing of QC samples.
• Manage and approve QC shipments, including generation of quotes and sample submission forms.
• Provide guidance and perform advanced analytical and microbiological testing for in-process materials and finished vaccine products.
• Support environmental monitoring activities, including environmental monitoring of production clean rooms and sampling/testing of in-house purified water, WFI, and clean steam.
• Train and mentor staff on stability procedures, analytical techniques, and regulatory requirements.
• Provide all job-related progress reports or technical reports, as requested, in a timely manner.
• Ensure compliance with safety and occupational health regulations, reporting any infractions to the Safety Officer.
• Perform light duties and other related duties as required and assigned.

Benefits

• Medical, dental, and vision insurance for individuals and families.
• FSAs, HSA.
• Life and AD&D insurance.
• Short- and long-term disability.
• Legal services.
• Voluntary hospital indemnity, critical illness and accident insurances.
• EAP.
• Pet insurance.
• 401(k) with employer match and Roth option.
• Tuition and professional reimbursement.
• Public transportation support in the DMV area.
• Referral bonus program.
• Vacation with tenure-based increases.
• PTO.
• 11 paid holidays.
• Paid bonding leave.
• Paid supplemental short-term disability.

What This Job Offers

• Career Level: Senior
• Industry: Personal and Laundry Services
• Education Level: Bachelor's degree