Quality Engineer Specialist
4 weeks ago
One of our large Pharmaceutical clients is seeking a Quality Engineer Specialist to oversee and support an external manufacturer within Advanced Therapeutics in Rockville, Maryland. In this role, you will be providing quality oversight and validation support for manufacturing activities related to commercial operations for production of cell therapy products. You will also be maintaining quality systems and oversight to ensure the validation/qualification and operation of processes and procedures for this external site. Other responsibilities include:
- Acting as sponsor's representative and main point of contact for manufacturing decisions
- Providing oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, qualification protocols, validation plans, and validation summary report
- Developing and executing protocols and analyzing results for a variety of qualification and validation functions
- Resolving manufacturing issues and conducting deviation investigations, root cause analysis and the identification and implementation of CAPAs
- Authoring, reviewing, executing and approving technical documents updates such as SOPs, batch records, change control documents, technical protocols, validation documents and other GMP documentation
- Driving continuous improvement and process optimization efforts on quality standards, requirements, and overall best practices
Qualifications:
- Bachelor’s Degree in a Science or Engineering related field of study
- Minimum 3 years of experience in pharmaceutical manufacturing within cell & gene therapy
- Minimum 8 years of related quality engineering or validation manufacturing support experience
- Strong QMS and IQ/OQ/ PQ skills
Pay: $60.00-$70.00/hr (flexible based on experience)
Hours: Monday-Friday, 8:00am-4:30pm
Hiring Method: 6 month long contract with high likelihood for extension and/or permanent hire
Sick Time: Paid Holidays & 6 paid sick days annually
Benefits: Medical, Dental, Vision and 401K plans available
Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
-
Quality Engineer Specialist
4 weeks ago
Rockville, United States Insight Global Full timeOne of our large Pharmaceutical clients is seeking a Quality Engineer Specialist to oversee and support an external manufacturer within Advanced Therapeutics in Rockville, Maryland. In this role, you will be providing quality oversight and validation support for manufacturing activities related to commercial operations for production of cell therapy...
-
Quality Assurance Specialist
3 weeks ago
Rockville, United States EOI Consulting Group, LLC Full timeQA SpecialistSummary/Objective:The QA Specialist position is responsible for the review and approval of commissioning and validation protocols to support a major biopharma client for their shutdown. In addition to protocol review/approval, protocol deviation handling and providing guidance to issue resolution is imperative.The position is required to support...
-
Quality Assurance Specialist
3 weeks ago
Rockville, United States EOI Consulting Group, LLC Full timeQA SpecialistSummary/Objective:The QA Specialist position is responsible for the review and approval of commissioning and validation protocols to support a major biopharma client for their shutdown. In addition to protocol review/approval, protocol deviation handling and providing guidance to issue resolution is imperative.The position is required to support...
-
Veterinary Cardiology Specialist
7 days ago
Rockville, Maryland, United States CVCA Rockville - Cardiology Specialist Full timeAbout the Role:CVCA Rockville - Cardiology Specialist is seeking a highly skilled and dedicated Veterinary Cardiology Specialist to join our team. As a key member of our cardiac team, you will play a vital role in providing exceptional patient care and contributing to the success of our practice.Responsibilities:Assist cardiologists with key technical work,...
-
Validation Engineer IV
3 months ago
Rockville, United States Quality Agents Full timeJob DescriptionJob DescriptionSalary: Hourly TBDQuality Agents, LLC is a service company offering validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation Engineers will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites. ...
-
Validation Engineer II
3 months ago
Rockville, United States Quality Agents Full timeJob DescriptionJob DescriptionSalary: Hourly TBDQuality Agents, LLC is a service company offering validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation Engineers will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites. ...
-
Quality Engineer
2 months ago
Rockville, Maryland, United States Pioneer Data Systems Inc Full timeOur client, a world-leading Pharmaceutical Company in Rockville, MD is currently looking for a Quality Engineer to join their expanding team.Job Title: Quality Engineer / Prodigy CAR-T Manufacturing / Hybrid WorkHybrid: onsite 3-4 days a weekThe client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.You...
-
Quality Specialist III
3 weeks ago
Rockville, United States MilliporeSigma Full timeThis is a 6-8 month contract to hire opportunity!Schedule: M-F 8am-5pmPay: $35-38/hr (depending on experience)First 2-3 months will be 100% onsite. Afterwards, will move to hybrid schedule (at least 3 days onsite).Who We Are:A leader in the life sciences. We aim to solve the toughest problems in the industry by collaborating with the global scientific...
-
Quality Specialist III
3 weeks ago
Rockville, United States MilliporeSigma Full timeThis is a 6-8 month contract to hire opportunity!Schedule: M-F 8am-5pmPay: $35-38/hr (depending on experience)First 2-3 months will be 100% onsite. Afterwards, will move to hybrid schedule (at least 3 days onsite).Who We Are:A leader in the life sciences. We aim to solve the toughest problems in the industry by collaborating with the global scientific...
-
GMP Quality Specialist
1 month ago
Rockville, United States Insight Global Full timeOne of our large Pharmaceutical clients is seeking a GMP Quality Specialist to oversee and support an external manufacturer within Advanced Therapeutics in Rockville, Maryland. In this role, you will be providing quality oversight for daily activities related to commercial operations supporting production of cell therapy products. Responsibilities...
-
GMP Quality Specialist
1 month ago
Rockville, United States Insight Global Full timeOne of our large Pharmaceutical clients is seeking a GMP Quality Specialist to oversee and support an external manufacturer within Advanced Therapeutics in Rockville, Maryland. In this role, you will be providing quality oversight for daily activities related to commercial operations supporting production of cell therapy products. Responsibilities...
-
CAR -T Quality Specialist
1 month ago
Rockville, United States Insight Global Full timeOne of our large pharmaceutical clients is seeking a CAR-T Quality Specialist to join their growing team in Rockville, MD. This position will perform manufacturing oversight of an external contract manufacturing organization producing a Phase Ib clinical CAR-T program as a person in plant. Additionally, this position will be responsible for supporting the...
-
CAR -T Quality Specialist
1 month ago
Rockville, United States Insight Global Full timeOne of our large pharmaceutical clients is seeking a CAR-T Quality Specialist to join their growing team in Rockville, MD. This position will perform manufacturing oversight of an external contract manufacturing organization producing a Phase Ib clinical CAR-T program as a person in plant. Additionally, this position will be responsible for supporting the...
-
Lead Quality Assurance Specialist
2 weeks ago
Rockville, Maryland, United States Savantage Full timeSavantage Solutions is in search of a Lead Quality Assurance Specialist to enhance our professional services team. The ideal candidate will possess a robust background in federal systems, federal finance, and Oracle APEX.Key Responsibilities:As a Lead Quality Assurance Specialist, you will be instrumental in guaranteeing the integrity, dependability, and...
-
Quality Assurance Engineer
7 days ago
Rockville, Maryland, United States PSC Biotech Corporation Full timePosition OverviewPSC Biotech Corporation stands at the forefront of the life sciences sector, committed to guaranteeing that healthcare products adhere to the utmost standards and regulatory mandates. Our international team, spanning North America, Europe, Asia, and the Middle East, collaborates to drive our clients towards success.Professional...
-
Lead Quality Assurance Specialist
1 day ago
Rockville, Maryland, United States Meso Scale Diagnostics LLC Full timeJob SummaryThe Lead Quality Auditor is a critical role within Meso Scale Diagnostics LLC, responsible for ensuring the company's quality systems and processes meet regulatory requirements. This position requires a strong background in auditing and quality assurance, with the ability to lead and mentor internal and external auditors.Key...
-
Quality Assurance Engineer
2 weeks ago
Rockville, Maryland, United States ConsultNet Full timeTitle: Mid SDET Location: anywhere in the continental US Type: Contract to Hire, Long term Contract Job Overview: ConsultNet is seeking a skilled Mid-Level Software Development Engineer in Test (SDET) to enhance our Quality Assurance team. This role is pivotal in ensuring the quality and reliability of our software products. Key Responsibilities: ...
-
Front-End Software Development Engineer
13 hours ago
Rockville, Maryland, United States Leidos Full timeJob SummaryWe are seeking a highly skilled Front-End Software Development Engineer to join our dynamic team at Leidos. As a UI/UX specialist, you will play a key role in designing, developing, and deploying state-of-the-art technology stacks to support our clients' mission-critical projects.Key ResponsibilitiesCoding, testing, and debugging new and/or...
-
Lead Contract Specialist
1 week ago
Rockville, United States Agency For Healthcare Research And Quality Full timeWHAT YOU'LL BE DOING DAY TO DAY As a Lead Contract Specialist, GS-1102-14, you will be: Developing acquisition plans with program officials to provide comprehensive contract management support effectively and efficiently. Executing and/or overseeing the entire contracting process from cradle to grave in conjunction with the program office. Developing...
-
Quality Assurance Validation Specialist
2 weeks ago
Rockville, Maryland, United States PSC Biotech Full timeJob OverviewPSC Biotech is dedicated to delivering critical services within the life sciences sector, ensuring that healthcare products are developed, manufactured, and distributed to meet the highest standards while adhering to all relevant regulatory requirements.Our mission is to elevate our clients' success, and your contributions can significantly...