QA Specialist IV

BioSpace

Frederick (MD)

On-site

USD 90,500 - 155,625

Full time

14 days+

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Benefits offered by this job

Competitive compensation

Health and Wellness programs

Paid Leave

Retirement benefits

Job summary

A biotech company in Maryland is seeking a QA Specialist IV to lead quality assurance activities. Candidates must have strong experience in GCLP and regulatory compliance, along with a bachelor's degree. The role involves maintaining documentation, developing risk management strategies, and leading internal audits. Competitive salary offered between $90,500 and $155,625 depending on experience.

Qualifications

Minimum eight (8) years of experience in quality assurance.
Experience in GCLP or GLP environments.
Ability to obtain a security clearance.

Responsibilities

Lead quality assurance activities in compliance with standards.
Evaluate conformance to quality assurance processes.
Develop risk management strategies.

Skills

Quality Assurance

GCLP

Regulatory Compliance

Education

Bachelor's degree

Tools

SOPs

Job description

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Job ID: req4316

Employee Type: exempt full-time

Division: Vaccine, Immunity and Cancer

Facility: Frederick: ATRF

Location: 8560 Progress Dr, Frederick, MD 21701 USA

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

Program Description

The Vaccine, Immunity and Cancer Directorate (VICD) at the Frederick National Laboratory investigates immune responses to vaccines in preclinical and clinical studies. The Frederick National Laboratory (FNL) and other stakeholders to develop assays with the highest reproducibility, sensitivity, and specificity for evaluation of immune responses against this new virus. To address gaps and unmet needs in serology assay development and standardization and to gain a solid fundamental knowledge of the immune response to underlying mechanisms of protection against infection, leveraging the vast expertise and excellence in HPV serology at the FNL.

Key Roles/Responsibilities

The Vaccine, Immunity and Cancer Directorate is seeking an energetic and seasoned Quality Assurance professional with experiences preferably in Serology laboratory with strong knowledge in GCLP to lead and support laboratory quality activities. This is a fully onsite position with no telework option. The QA professional will:

Lead and perform continuous evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards
Evaluation and monitoring of conformance to established quality assurance processes and standards for testing and laboratory practices
Identify risk and evaluate deficiencies while working with internal departments/business units to appropriately remedy them
Develop appropriate risk management strategies
Assist staff with the creation, implementation, and follow up of Corrective and Preventive Actions
Recommend alternative courses of action and possible solutions for improvement of workflow, and paperwork management
Work with laboratory director and manager to plan, qualify, verify, and validate tests/assays and equipment
Work closely with the laboratory to write SOPs and Quality Assurance plans appropriate for each group
Participate in the review and revision of standard operating procedures to adhere to regulations
Working closely with appropriate staff, prepare standard operating procedures for quality control activities
Review documents for content, accuracy and compliance
Develop and monitor quality assurance standards
Prepare guidance documents
Review records, test results and data for completeness, accuracy, and compliance with specifications and requirements
Facilitate internal training and quality assurance requirements, processes, and procedures, and maintain training records for staff
Maintain document control system and ensure version control for all standard operating procedures
Lead and perform internal audits and risk assessments
Implement training programs for laboratory personnel on quality assurance requirements, processes, and procedures
Ensure compliance with SOPs, GCLP/CLIA regulations, and FDA as applicable

Basic Qualifications

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
In addition to the education requirement, a minimum of eight (8) years of leading quality assurance in GCLP or GLP environment.
Highly experienced in GCLP or GLP, CLIA.
Ability to obtain and maintain a security clearance.

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

Experience in quality control and quality assurance related to immunology, virology and/or molecular biology procedures for reagent production and assay development and performance.
Strong understanding of regulatory and GCLP/CLIA requirements.
Experience working with standards and reference materials, immune assay (ELISA, multiplex assays) development and validation.
Excellent communication, organization, and writing skills.

JOB HAZARDS

This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay And Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

90,500.00 - 155,625.00

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions

Seniority level