Quality Assurance Specialist

2 months ago


Frederick, United States ATR International Full time
Job DescriptionJob Description

Job Title: Quality Assurance Specialist

Type: Contract - 6 Months

Shift - Shift is Sunday – Wednesday 7am- 5:30 pm

Location: Frederick, MD

Pay: $34.00/hr

 

We are seeking a Quality Assurance Specialist for a very important client.

We are seeking a highly motivated individual to join us as a Quality Assurance Specialist. In this role you will support the activities of the Quality Assurance department at Kite’s Frederick, MD manufacturing site. The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives.

Responsibilities (included but not limited to):

• Provide QA support on the floor for production

• Ensure process control measures are in place and followed in product manufacturing

• Receipt and disposition of incoming apheresis material.

• Oversee and authorize shipment of final product

• Verify and ensure timely issuance of production documents and labels

• Review batch-related documentation and ensure resolution of issues to release and ship product.

• Gather and report metrics to measure performance

• Identify continuous improvement actions

• Ensure timely resolution and escalation of issues

• Ensure all product-related Deviations are initiated, investigated and resolved.

• Ensure that associated CAPAs are initiated and resolved, as needed.

• Perform lot closure activities.

• Ensure approval and timely delivery of final product.

• Ensure products are manufactured in compliance with regulatory and GMP guidelines.

• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.

• Perform other duties as assigned

 

Basic Qualifications:

• BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR

• Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR

• High School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).

 

Preferred Qualifications:

• BS/BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.

• Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards

• Ability to effectively negotiate and build collaboration amongst individuals

• Strong teamwork and collaborative skills

• Experience with manufacturing investigations, deviations, and CAPA.

• General knowledge of aseptic manufacturing processes.

• Proficient in MS Word, Excel, Power Point and other applications.

• Strong interpersonal, verbal and written communication skills

• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities

• Willingness to think outside of the box and adapt best practices to a small, but growing environment

• Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies

• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.



  • Frederick, Maryland, United States Pave Talent Full time

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a detail-oriented Quality Assurance Specialist to join our team on third shift. As a Quality Assurance Specialist, you will play a crucial role in maintaining product quality and ensuring compliance with food safety standards.Key Responsibilities:Conduct verifications of manufacturing...


  • Frederick, Maryland, United States RICEFW Technologies Full time

    Job Title: Quality Assurance SpecialistJob Summary:RICEFW Technologies is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products by performing testing and analysis of raw materials, intermediates, and final products. You will also be...


  • Frederick, Maryland, United States Varite Full time

    Job Summary:As a Quality Assurance Specialist at Varite, you will provide critical support to our documentation processes and systems. Your responsibilities will include creating logbooks and control-issued documents, maintaining the document archival room, and ensuring the accuracy and retrievability of files. You will also scan, verify, and archive...


  • Frederick, Maryland, United States Mindlance Full time

    Job Title: QA AssociateAt Mindlance, we are seeking a highly organized and detail-oriented Quality Assurance Specialist to join our team. The successful candidate will provide clerical and administrative support related to documentation processes and systems. Key responsibilities include creating logbooks and other control issued documents, maintaining the...


  • Frederick, Maryland, United States BioSpace, Inc. Full time

    Job Title: Lead GCLP Quality Assurance SpecialistJob Summary:The Frederick National Laboratory is seeking a highly skilled Lead GCLP Quality Assurance Specialist to join our team. As a key member of our laboratory, you will be responsible for leading continuous performance evaluation of internal controls, communications, risk assessments, and maintenance of...


  • Frederick, Maryland, United States eTeam Full time

    Job Summary:As a Quality Assurance Specialist at eTeam, you will be responsible for providing clerical and administrative support related to documentation processes and systems. This includes creating logbooks and other control issued documents, assisting in maintaining the document archival room, and ensuring files are accurate and easily retrievable. You...


  • Frederick, United States Frederick National Laboratory for Cancer Research Full time

    Quality Assurance Specialist IV Job ID: req4048Employee Type: exempt full-timeDivision: Vaccine, Immunity and CancerFacility: Frederick: ATRFLocation: 8560 Progress Dr, Frederick, MD 21701 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by...


  • Frederick, Maryland, United States Srisai Biopharmaceutical Solutions Full time

    At Srisai Biopharmaceutical Solutions, we are seeking a talented Quality Assurance Compliance Specialist to join our dynamic and collaborative team. As a key member of our QA team, you will play a critical role in ensuring company compliance with approved procedures and applicable regulatory standards.The Compliance Specialist will work closely with the QA...


  • Frederick, Maryland, United States Cornerstone Recruiting Full time

    Job Summary:The Quality Assurance Technician is responsible for ensuring quality products are produced in the plant according to specifications. This includes ensuring food safety procedures are followed, customer expectations and specifications are met, and product quality and safety information is analyzed to identify trends.Key Responsibilities:Assure...


  • Frederick, Maryland, United States Walmart Full time

    About the Role:This position is responsible for overseeing patient safety and quality for pharmacy non-store operations at Central Fill facilities. The primary responsibility is to collaborate with various stakeholders within health and wellness to enhance patient safety and quality of care.Key Responsibilities:Investigate patient safety events, identify...


  • Frederick, Maryland, United States SriSai Biopharmaceutical Solutions. LLC Full time

    Job Summary:We are seeking a talented Quality Assurance Compliance Specialist to join our dynamic and collaborative team at SriSai Biopharmaceutical Solutions, LLC. As a key member of our tech team, you will work closely with the QA Manager and QA Supervisor to ensure company compliance with approved procedures and applicable regulatory standards.Key...


  • Frederick, United States SriSai Biopharmaceutical Solutions. LLC Full time

    Join Our Growing Biopharma Tech Team!Location: Frederick, MDStatus: Full-Time, Non-ExemptAre you passionate about cutting-edge technology and making a real-world impact in the rapidly growing biopharmaceutical industry? Join SriSai Biopharmaceutical Solutions (SBS), a company driven by innovation and committed to developing life-saving solutions. We're...


  • Frederick, United States SriSai Biopharmaceutical Solutions. LLC Full time

    Join Our Growing Biopharma Tech Team!Location: Frederick, MDStatus: Full-Time, Non-ExemptAre you passionate about cutting-edge technology and making a real-world impact in the rapidly growing biopharmaceutical industry? Join SriSai Biopharmaceutical Solutions (SBS), a company driven by innovation and committed to developing life-saving solutions. We're...


  • Frederick, Maryland, United States Cornerstone Recruiting Full time

    Job Summary:Cornerstone Recruiting is seeking a Quality Assurance Technician to ensure quality product is produced in the plant according to specifications. The successful candidate will be responsible for ensuring that all food safety and quality procedures are followed, and that the facility meets customer expectations and specifications.Key...


  • Frederick, Maryland, United States ATR International Full time

    Job Summary:We are seeking a highly detail-oriented and organized individual to join our team as a QA Associate I. As a key member of our quality assurance team, you will be responsible for providing clerical and administrative support related to documentation processes and systems.Key Responsibilities: Creates logbooks and other control issued documents...


  • frederick, United States Scientific Search Full time

    Director, Quality Assurance & CMC Regulatory                                                                                                                                             Onsite Frederick, MDWhat you can expect to do:  Assure the quality, safety, and compliance of ancillary...


  • Frederick, Maryland, United States Ampcus Full time

    About AmpcusAmpcus is a leading provider of innovative solutions for the life sciences industry. We are seeking a highly skilled QC Information Systems Specialist to join our team.Job SummaryWe are looking for a detail-oriented and organized QC Information Systems Specialist to manage computerized systems and business analyst between lab groups and IT for...


  • Frederick, Maryland, United States Theradaptive Full time

    Job Summary:We are seeking a highly motivated Senior Quality Engineer to join our team at Theradaptive. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance are met for our organization.This role will play a pivotal part in establishing and maintaining robust quality systems and processes...


  • Frederick, United States Link Solutions, Inc. Full time

    Job DescriptionLink Solutions is seeking an Information Assurance Specialist to join our team in support of the US Army's Medical Material Development Activity (USAMMDA) at Fort Detrick, MD.Must be a US Citizen Non-remote (relocation incentive available)The Information Assurance Specialist will plan, coordinate, integrate, implement, manage, and...


  • Frederick, United States Link Solutions, Inc. Full time

    Job DescriptionLink Solutions is seeking an Information Assurance Specialist to join our team in support of the US Army's Medical Material Development Activity (USAMMDA) at Fort Detrick, MD.Must be a US Citizen Non-remote (relocation incentive available)The Information Assurance Specialist will plan, coordinate, integrate, implement, manage, and...