QC Specialist - EM and Micro Testing

Asahi Kasei Plastics North America, Inc.

Fremont, California

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JOB DETAILS

SALARY

$80,000–$100,000

SKILLS

Analysis Skills, Biology, Business Growth, Cell Cultures, Change Control, Cleanroom, Communication Skills, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Relations, Detail Oriented, Environmental Monitoring, Equipment Maintenance/Repair, GMP (Good Manufacturing Practices), Healthcare, Instrumentation, Interpersonal Skills, Laboratory Equipment, Lift/Move 25 Pounds, Manufacturing, Microbiology, Order Management, Order Supplies, Organizational Skills, Patient Care, Presentation/Verbal Skills, Problem Solving Skills, Procedure Implementation, Quality Control, Regulatory Reports, Regulatory Submissions, Reporting Skills, Resolve Customer Issues, Root Cause Analysis, Staff Training, Standard Operating Procedures (SOP), Team Player, Technical Writing, Testing, Trend Analysis, Validation Plan, Writing Skills

LOCATION

Fremont, California

POSTED

8 days ago

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company:
Bionova Scientific LLC

Job Description:

Company Summary:

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.

Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.

Position Summary:

The QC Lab at Bionova is seeking a self-motivated, innovative, and team-oriented QC Analyst with strong technical and communication skills to support microbiology testing of biologics. In this role, you will contribute to a dynamic and expanding business as part of a rapidly growing Quality Control team. You will have the opportunity to influence decisions, collaborate cross-functionally, and develop your own skills while working toward project goals that ultimately improve patient outcomes.

Essential Duties and 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.

Working Conditions:

This position is required to work in a lab setting.

Must be able to lift, push, and carry up to 25 lbs.

Qualifications:

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.

Compensation Range: The base compensation range for this role i

About the Company

Asahi Kasei Plastics North America, Inc.

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