Matica Biotechnology, Inc. · 1 month ago
Analyst II, Quality Control
Matica Biotechnology is at the forefront of biopharmaceutical research and development, seeking a highly motivated Quality Control professional to join their team. The Analyst II, Quality Control will assist the QC Team in day-to-day activities in the QC lab, performing routine assays and supporting cGMP manufacture of cell and gene therapy products.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Perform routine assays on various finished products, raw materials, and in-process samples
Record test results, document processing steps on Quality Control assays while adhering to good documentation practices (GDP)
Perform testing in conjunction with laboratory investigations and deviations
Interface with Analytical Development (AD) to transfer, train, and qualify analytical methods
Execute method qualification and validation, tech transfer, and verification testing with minimal supervision
Participate in various special projects according to the needs of the department
Draft procedures and / or operating manuals, as needed
Participate in the qualification and calibration of laboratory instruments
Perform testing in support of facility validation activities
Train QC personnel as appropriate
Collaborate with cross-functional teams to resolve complex method development challenges
Responsible for participation in internal audits, client audits and agency inspections of the site
Ability to communicate and work in a fast-paced team environment
Ability to work both independently and in a team-oriented environment
Support internal and external cGMP manufacture and supply of high-quality cell and gene therapy products including in-process testing, QC release and stability data analyses and method data trending, deviations, out of specification investigations, and Certificates of Analysis creation
Perform routine inventory
Ensure lab is maintained (organized, clean, & properly supplied)
Observe and report any safety issues
Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure Quality Control functions remain in compliance with applicable company requirements and global regulations
Maintain a high level of integrity and professionalism when interacting with co-workers and clients
All other duties as assigned by Quality Control Management
Qualification
Required
BS/BA or greater in sciences, preferably in chemistry, biochemistry, biotechnology, pharmaceutical sciences, or related technical field
Or 6+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing or laboratory environment
2+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing or laboratory environment
Working knowledge of aseptic practices and clean room operations
Working knowledge of statistical and auditing techniques
Working knowledge of environmental control procedures/equipment
Working knowledge of GMP, FDA, ICH, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
Current industry trends and can use the latest technologies
Must be flexible and able to prioritize multiple tasks and assignments
Ability to interpret cGMPs and apply to non-routine situations
Must have strong verbal and written communication skills and comfortably and clearly articulate issues with peers and colleagues at all levels in the organization
Demonstrated capability in cross function team environment, working collaboratively with others in effective ways which attain goals while encouraging teamwork and synergies throughout the organization
Ability to make informed and timely decisions
Document work clearly and perform tests accurately in alignment with good documentation practices (GDP)
Ability to learn new techniques
Highly motivated in the QC field with sustained performance and accomplishments
Ability and experience in turning around and remediating compliance challenges
Diplomacy, negotiation skills, team building skills
Written and oral communication skills
Independent work skills and strong work ethic
Preferred
Experience with ddPCR, qPCR, HPLC, ELISA, Microscopy, and Flow Cytometry
Company
Matica Biotechnology, Inc.
Matica Biotechnology, Inc.
H1B Sponsorship
Matica Biotechnology, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (2)
2023 (4)
2022 (1)
2021 (1)
Funding
Current Stage
Growth StageRecent News
Precedence Research
2025-11-27
2025-11-04
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