Asahi Kasei Bioprocess America, Inc. ยท 1 week ago
QC Specialist - EM and Micro Testing
Fremont, CA
Full-time
Onsite
Mid Level
$80K/yr - $100K/yr
4+ years expAsahi Kasei Bioprocess America, Inc. is focused on creating for tomorrow through various business sectors. They are seeking a QC Specialist to support microbiology testing of biologics, contributing to a dynamic Quality Control team and influencing decisions while improving patient outcomes.
BiotechnologyManufacturing
Responsibilities
Perform microbiology testing for routine EM, release, stability, and method verification samples
Read plates from environmental monitoring and media fill
Perform growth promotion, and Gram Staining
Perform endotoxin, TOC, and bioburden testing
Enter data in electronic systems and LIMS
Manage and orders supplies as needed for testing
Assist in QC team implementation of GMP procedures, processes, and systems
Train QC staff on instrumentation, techniques, microbiology methods
Initiate trend reports
Author/review/approve technical documents such as method qualification/validation/transfer protocols and reports, and regulatory filing documents per project needs
Initiate/Investigate deviations, Change control and CAPA
Maintain lab equipment as appropriate per procedures
Contribute to investigation of issues and non-conformities to products and projects and perform troubleshoot of equipment and testing procedures to identify root causes of issues and participate in lab investigations
Help in maintaining the QC lab in a clean, organized and compliance at all times
Perform other QC tasks as required
Qualification
Required
Bachelor's Degree or above from an accredited institution in Microbiology, Biology (or closely related degree)
Requires 4+ years of quality pharmaceutical, bio-pharmaceutical, or combi-medical device experience, and analytical testing experience on Biologics
An energetic scientist and a creative thinker who can explore and identify better and more efficient methods to address issues and gaps
Demonstrate ability to work independently and on cross-functional teams
Strong attention to detail and following procedures and requirements
Effective verbal and written communication skills
Great interpersonal and teamwork skills
At least 2 years of Technical Writing skills such as SOP, CAPA, deviation reports etc
Benefits
Health Benefits and Program: Bionova offers health benefits at a subsidized rate.
Healthcare, Dental, and Vision insurance
Life Insurance and Disability Program: 100% covered by Bionova.
Retirement Plan (401K) Up to 8% of Employer Match
Paid time off up to two weeks
10 days of Holidays and 5 days of Sick Leave.
Company
Asahi Kasei Bioprocess America, Inc.
As a global partner to the biopharmaceutical industry, Asahi Kasei Bioprocess helps biologics manufacturers safely and efficiently produce medicines that patients can trust, by dependably supplying innovative yet exceptionally reliable bioprocess consumables, equipment and scientific support services.
51-200 employees
H1B Sponsorship
Asahi Kasei Bioprocess America, 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (1)
2022 (2)
2021 (2)
Funding
Current Stage
Growth StageLeadership Team
Daniel Strauss
Director of R&D
Recent News
GlobeNewswire News Room
2025-02-25
2025-02-18
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