ProZyme, Inc., established in 1990, specializes in the development of value-added reagents, kits and platforms for improved analytical results. Technologies used include: microbial fermentation sciences; large-scale native and recombinant purification and formulation; assay development and analytical services for our customers. Analytical methods employed include HPLC, CE, bead-based immunassays and ELISA’s.

Most recently ProZyme has commercialized the GlykoPrep™ Sample Preparation Platform to significantly speed and simplify sample preparation for glycoanalysis, yielding high-quality results to support all stages of biopharmaceutical drug development and manufacture.

ProZyme’s strives to:

∙ Create value and job enjoyment and satisfaction using employees’ skills, experience, and technological strengths;
∙ Focus on customer needs while adding value;
∙ Encourage responsible risk-taking;
∙ Push for profitability and growth without compromising quality; and
∙ Drive innovation.

The QA/QC Scientist is responsible for developing processes, writing SOP’s and other operating procedures to enable the setup and implementation of the Analytical QC Lab, to facilitate the capability to achieve ISO17025 and/or GLP certification. This position will administrate, facilitate and track Design Control documentation requirements, ensuring timely and effective completion of documentation for new product transfer. They will be an integral part of Design Control Teams. They will perform analytical QC testing and support for the Analytical QC group. Functions include testing for Analytical Services and product release, writing of procedures and methods, writing reports, preparation of related documents (Certificates of Analysis, labels), complaint investigations, stability testing and associated data analysis.

This candidate will be responsible for the following QC-related activities:

∙ Develop processes and procedures to implement an Analytical QC Lab, capable of achieving certification when fully implemented, according to the Analytical QC Charter.
∙ Investigate customer complaints and other nonconformances where applicable, using quality tools and various data sources in order to determine causes of quality issues.
∙ Participate on Design Control Teams and is the Administrator for the documentation aspect of Design Control. Assist in method transfer of new products from PDC to QC, including proposal of verification protocols and reviewing documents.

And will also function in and be responsible for the following related activities:

∙ Apply knowledge of good manufacturing and laboratory practices on a daily basis.
∙ Apply critical thought to solving problems of complex scope in which analysis of situations or data requires an in-depth evaluation of various factors.
∙ Act independently to determine methods and procedures on new assignments.
∙ Daily operations in the laboratory: performance of assays, review of data, updating control charts, metrics and equipment logbooks; documentation and writing of reports.
∙ Complete appropriate documentation to support testing procedures including data capture forms, equipment logbooks, electronic systems, reports and inventory forms.
∙ Investigate and document out-of-specification results and deviations within established time frames.
∙ Train others in improved methods and quality practices.
∙ Adhere to Company safety procedures and guidelines on a daily basis.
∙ Participate in Proficiency Testing and in Quality Audits.
∙ Participate in re-assays, stability studies and other types of studies, as appropriate.
∙ Write and perform equipment qualifications (IQ/OQ/PQ) for Analytical QC Lab.
∙ Identify and leverage opportunities to improve the quality management processes, systems, and standards.
∙ As time permits, work with Manufacturing to transfer QC assays to Analytical QC.
∙ Other tasks as approved.

Qualifications (Knowledge/Skills/Abilities) & Experience:

Candidates should have 5-8 years of experience in a life science environment using various analytical assays, enzyme-based assays and general laboratory testing. May include post doctoral experience. Experience in a Clinical Research Organization (CRO) is an advantage.

In addition to this, an ideal candidate has working knowledge of analytical instrumentation such as HPLC, fluorescence, and UV/VIS as well as statistical tools for data analysis.

Strong oral and written communication skills, excellent laboratory skills including attention to detail required.

∙ Independence and good organization skills
∙ Critical thinking and attention to detail
∙ Expert knowledge of scientific principals and concepts
∙ Statistics and analytical technologies
∙ Ability to multitask and produce quality results under tight timelines with sound documentation
∙ Ability to work with other departments to effectively perform Analytical Testing Services and to release quality products withing schedule
∙ Excellent communication and team working skills, both within the Quality Team and within cross-functional teams
∙ Quality systems experience (CRO, ISO 9000, ISO 17025 and/or QSR)
∙ Experience with CAPA investigations, root cause analysis and corrective and preventive action resolutions
∙ Knowledge of GMP/GLP

Education:

Candidates should have a PhD in Life Science or equivalent.

ProZyme, Inc., is proud to be an equal opportunity employer. Based in Hayward, CA, ProZyme provides the opportunity for employees to grow and develop careers that support the mission of the company. ProZyme considers the empowerment, recognition and professional development of our people–our most valuable resource–our first commitment.

If you are interested in exploring opportunities with ProZyme, please send your resume to the email above or visit www.prozyme.com

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