Quality Assurance Specialist, (Product)

Job Title: Quality Assurance Specialist, (Product)

Position Type: Contract (Temp to hire)

Location: Rockville, MD

Salary Rate: $28-$33/hr on W2

Job ID#: 148132

Responsibilities and Duties:

• Responsible for the initiation, revision, distribution, and version control of documents and labels following GDP requirements.
• Responsible for performing Quality Assurance review of batch related documentation including
• batch records, COAs, test records, etc. and preparation of batch documentation.
• Responsible for tracking the chain of custody and chain-of-identity for batches
• Provide Quality Assurance oversight for QC activities including stability, method qualifications,OOS, aborted and invalid assays, in-process, and final product testing etc.
• Provide Quality Assurance support for the technical release of clinical batches.
• Responsible for the management, control and release of critical materials and starting materials.
• Perform quality investigations of manufacturing Deviations, GMP and Quality System issues, non-conforming materials, change requests, and CAPA
• Participate in the management of day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities related to product
• Perform other duties that may be assigned.

Qualifications and Requirements:

• Bachelor’s Degree in life science or a related scientific discipline, 1-3 years experience in quality Assurance roles
• Working knowledge of cGMP principles with respect to FDA regulations
• Workable knowledge of aseptic processing regulations and guidelines
• Sufficient understanding of phase appropriate Quality System implementation and maintenance
• Knowledge and experience with a risk-based approach to Quality System implementation
• Previous experience working with clinical-stage biological products such as antibodies, vaccines, or recombinant antibodies.
• Strong communication and coordination skills, good language skills, and the ability to analyze and solve problems with a positive work attitude.
• Ability to work in a dynamic, fast-paced environment with shifting priorities
• Ability to work collaboratively with teams and collaborators
   

About Us:

Founded in 2009, IntelliPro stands as a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. With a dynamic presence in the USA, China, Canada, Singapore, Philippines, UK, India, Netherlands, and Germany, we continue to lead the way in global talent solutions.

IntelliPro, a global leader in connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected groupstatus. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at https://intelliprogroup.com/.