Senior Quality Assurance Audit Specialist

19 hours ago

Silver Spring, United States CAMRIS International Full time
Overview

We are seeking a Senior Quality Assurance Audit Specialist 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 diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.   

Responsibilities
  • Provides comprehensive quality support to PBF departments to ensure and enhance compliance with current Good Manufacturing Practices (cGMPs). This includes support in the development of instructional documents [standard operating procedures (SOPs), batch production records], review of executed documents (batch records), internal/On-the-Floor (OTF) auditing for GMP compliance, mentoring/coaching employees in GMP compliance, participation in investigations, and follow-up to verify that identified corrective/preventive actions have been appropriately implemented.  Also assists in the execution of other Quality Assurance department responsibilities..'
  • Leads in the implementation/revision of specific quality system projects.
  • Learns and maintains an understanding of and training in using the PBF quality and documentation systems. Follows existing SOPs.
  • Follows cGMP guidelines and FDA regulations as they apply to all levels of work.
  • Assists departments in creating Batch Production Records, departmental procedures and policies, logbooks, etc.
  • Performs review of completed batch records to determine compliance with all established, approved written procedures and works with departments to resolve discrepancies; monitors status of batch records until completed; prepares Certificates of Analysis for completed lots.
  • Assists departments in the initiation of deviations.
  • Assists in and conducts investigations.
  • Works with departments to enhance compliance and productivity. Coaches and mentors staff to improve GMP understanding and application.
  • Inspects labeling prior to use for accuracy, completeness, and compliance with approved labeling specifications. Performs label reconciliation after use.
  • Performs internal audits to determine compliance with established, approved written procedures. Works with the audited department to resolve discrepancies and enhance compliance and productivity.
  • Verifies that identified corrective/preventive actions have been implemented.
  • Serves as an emergency responder in the event of freezer/refrigerator failure in order to protect inventory at risk.
  • Maintains a safe workplace; observe appropriate safety and occupational health rules and regulations. The employee is required to attend safety training relative to the position.
  • Provides technical assistance to CAMRIS headquarters as needed and participates in proposal writing projects when requested.
  • Performs light duties and other related duties as required and assigned.
Qualifications
  • At least a BS/BA in biology or another life science field and 10 years of experience. Master's degree is preferred.
  • A minimum of 6 years at a cGMP biotechnology, pharmaceutical, or related facility with at least 4 years of experience in QA.
  • At least intermediate skills in Word and Microsoft Excel, along with good grammar, spelling, and proofreading skills and attention to detail. Skills in Microsoft Access and LIMS systems are a definite plus.
  • Able to work independently and with significant initiative.  Some nights or weekends may be required.
  • Aseptic gowning and entering cleanrooms may be required.
  • Able to follow directions and written policies and procedures for all work responsibilities.
  • Good people and communication skills (written and verbal).
  • Must be eligible to work in the United States and have lived in the United States for three of the past five years if a non-US citizen.

Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

CAMRIS offers a comprehensive benefits package to support your health, well-being, and financial security. Our offerings include medical, dental, and vision insurance, FSAs and HSA, life and disability coverage, retirement plans with employer match, tuition reimbursement, public transportation support in the DMV area, and generous paid time off. Additional benefits include legal services, pet insurance, and an employee referral bonus program.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education, and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully complete any required background check questionnaire during initial onboarding.

  • Senior Quality Assurance Audit Specialist

    1 week ago

    Silver Spring, United States CAMRIS International Full time

    We are seeking a Senior Quality Assurance Audit Specialist 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 manufa Audit Specialist, Quality Assurance, Assurance, Audit, Quality, Specialist, Technology

  • Senior Care Specialist

    6 days ago

    Silver Spring, Maryland, United States Sunrise Senior Living Full time

    About Our TeamSunrise Senior Living is a champion of quality of life in senior care, committed to delivering high-quality care with a personal touch. As a Senior Care Specialist, you will play a vital role in enhancing the lives of our residents and their families.Key Responsibilities:Resident Support: Provide personalized support to a consistent group of...

  • Healthcare Quality Assurance Specialist

    1 week ago

    Silver Spring, United States Incredible Health Full time

    Incredible Health is actively hiring for a Registered Nurse - Quality Assurance Coordinator in the Silver Spring, MD area. This role involves ensuring high-quality patient care and outcomes by reviewing and implementing evidence-based practices.Key Responsibilities:Review and analyze data to identify areas for improvementDevelop and implement quality...

  • Senior Payroll Specialist

    1 week ago

    Silver Spring, Maryland, United States Sparks Group Full time

    Job Title: Senior Payroll SpecialistSparks Group is seeking a skilled Senior Payroll Specialist to contribute to the efficient and accurate processing of payroll for a reputable healthcare organization.This role involves reviewing and resolving payroll discrepancies, maintaining employee data, and ensuring compliance with federal and state...

  • Registered Nurse

    2 months ago

    Silver Spring, United States Incredible Health Full time

    Hospitals on Incredible Health are actively hiring and accepting applications in the Silver Spring, MD area for the following position: Registered Nurse - Quality Assurance Coordinator. Nurses with experience in any of the following areas are strongly encouraged to apply: Assistant Nurse Manager, Audit, CNO, Charge, Clinical Nurse Coordinator, Director,...

  • Care Coordinator for Quality Senior Living

    1 week ago

    Silver Spring, Maryland, United States Sunrise Senior Living Full time

    Join Our Team as a Care CoordinatorSunrise Senior Living is a leader in senior care, providing quality services and support to seniors and their families. As a Resident Assessment Coordinator/MDS Manager, you will play a vital role in ensuring the highest level of care for our residents.About UsWe are committed to championing quality of life for all seniors....

  • Director, Internal Audit

    4 months ago

    Silver Spring, United States Z1 Discovery Communications LLC Full time

    Who We Are… When we say, “the stuff dreams are made of,” we’re not just referring to the world of wizards, dragons and superheroes, or even to the wonders of Planet Earth. Behind WBD’s vast portfolio of iconic content and beloved brands, are the bringing our characters to life, the bringing them to your living rooms and the creating what’s...

  • Quality Assurance Manager

    4 weeks ago

    Spring Hill, Florida, United States Comprehensive Logistics Full time

    Quality Assurance ManagerComprehensive Logistics Co. Inc. is driving innovation and momentum through its agile diversification into new markets, expanding its current market base, and fostering a culture of continuous improvement. As a Quality Assurance Manager, you will play a critical role in shaping the company's quality management system, ensuring...

  • Certified Senior Nurse Practitioner

    1 week ago

    Silver Spring, Maryland, United States Sunrise Senior Living Full time

    Job Title: Certified Senior Nurse Practitioner - Silver Spring MDCompany OverviewSunrise Senior Living is a leading provider of senior care services, committed to delivering high-quality care and promoting the well-being of our residents. With over 30 years of experience, we have established a reputation for excellence in the industry.Salary: $1.00 shift...

  • Residential Construction Quality Assurance Specialist

    3 days ago

    Spring Hills, Texas, United States Signorelli Company Full time

    Job OverviewFirst America Homes, a subsidiary of The Signorelli Company, is seeking a skilled Residential Construction Quality Assurance Specialist to join their team in Texas. This role plays a vital part in ensuring the quality of new homes, from pre-drywall stages to completion.

  • Communications Specialist

    3 weeks ago

    Silver Spring, United States Erickson Senior Living Full time

    Location: Riderwood Village by Erickson Senior Living Join our team as a Communications Specialist (Front Desk), a crucial role within our community. As the first point of contact for residents, family members, and candidates, you'll set the tone for their experience and ensure a warm and welcoming environment. What we offer: Compensation: $17.50-18.50...

  • Senior Care Professional

    4 days ago

    Silver Spring, Maryland, United States Sunrise Senior Living Full time

    About the RoleAs a Caregiver Specialist at Sunrise Senior Living, you will play a vital role in creating a warm and welcoming environment for our residents. You will be responsible for assisting with daily activities, such as bathing, dressing, and grooming, as well as participating in life-enriching programs and activities designed to promote mental and...

  • Medical Support Professional

    5 days ago

    Silver Spring, Maryland, United States Specialist Office Full time

    Job SummaryThis Medical Support Professional role is an exciting opportunity to join our team at Specialist Office in Silver Spring, MD. As a key member of our clinical staff, you will be responsible for providing high-quality patient care and support to our physicians and physician assistants.

  • Quality Assurance Development Specialist

    6 days ago

    Spring Grove, Illinois, United States SCOT FORGE Full time

    At Scot Forge, we're seeking a Quality Intern to join our team for the Summer of 2025. This is a paid internship that offers hands-on experience with exposure to our manufacturing processes and procedures.Program OverviewPaid Compensation: $15-$20/hour (estimated annual salary: $40,000-$50,000)This program provides valuable experience in quality assurance,...

  • Quality Assurance Specialist Nurse

    1 week ago

    Spring Hill, Florida, United States The Tampa General Hospital Full time

    The Tampa General Hospital is seeking a Quality Assurance Specialist Nurse to join our team.Job SummaryWe are looking for an experienced RN with a strong background in quality improvement and clinical expertise to work under the supervision of the Chief Quality Officer. The ideal candidate will have 3-5 years of experience in acute care hospital nursing or...

  • Geriatric Care Specialist | Silver Spring

    1 week ago

    Silver Spring, Maryland, United States Sunrise Senior Living Full time

    Job Overview:Sunrise Senior Living, a leader in senior care, is seeking a dedicated and compassionate Geriatric Care Specialist to join our team. As a member of our care-focused environment, you will have the opportunity to make a meaningful difference in the lives of our residents.About Sunrise Senior Living:We are passionate about championing quality of...

  • On Call/PRN Communications Specialist

    4 weeks ago

    Silver Spring, United States Erickson Senior Living Full time

    Location: Riderwood Village by Erickson Senior Living Riderwood Village Silver Spring is hiring a Communications Specialist for our award winning community. This is an essential role within our community, you will often be the first person a resident or family member meets! What we offer: Compensation: $16.00 - $19.00 per hour including shift differential...

  • On Call/PRN Communications Specialist

    4 weeks ago

    Silver Spring, United States Erickson Senior Living Full time

    Location: Riderwood Village by Erickson Senior Living Riderwood Village Silver Spring is hiring a Communications Specialist for our award winning community. This is an essential role within our community, you will often be the first person a resident or family member meets! What we offer: Compensation: $16.00 - $19.00 per hour including shift differential...

  • Senior Medical Laboratory Specialist

    7 days ago

    Silver Spring, Maryland, United States Maryland Oncology Full time

    Overview: Maryland Oncology Hematology is seeking an experienced Medical Laboratory Scientist to join our team. As a Senior Medical Laboratory Specialist, you will play a crucial role in delivering high-quality laboratory services to our patients.

  • Senior Benefits Analyst

    1 week ago

    Silver Spring, United States Choice Hotels Full time

    Who are we looking for? Choice Hotels, one of the world’s largest lodging franchisors, has an exciting new opportunity as our Senior Benefits Analyst in the Total rewards department. The Senior Analyst, Benefits is responsible for implementing, administering, ensuring compliance, analyzing, and reporting on all Choice Hotels employee benefits programs....