(CW) QC Analyst Contract

BioMarin Pharmaceutical Inc.; Novato (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

BioMarin Pharmaceutical Inc. is seeking a QC Analytical In-Process (QCA-IP) Analyst to perform analytical test methods on in-process intermediates and drug products under cGMP guidelines. The role supports manufacturing for clinical and commercial therapeutics with oversight from a contract arrangement.

The position requires a BS degree and 0–3 years of QC lab experience, with familiarity in HPLC/UPLC, protein assays, and data analysis. Onsite work in Novato, CA, with a 4-day swing shift.

Qualifications

• Bachelor of Science degree.
• 0-3 years of relevant laboratory experience; QC experience preferred.
• Familiar with quality management systems and cGMP principles.
• Experience with certified functional activities.
• Strong documentation and communication skills.
• Ability to work with minimal supervision.
• Proficient in Microsoft Word and Excel; PowerPoint preferred.
• Familiarity with BINOCS or SAP is preferred.
• Willingness to work additional hours to meet lab needs.
• Quality service attitude and flexibility.

Responsibilities

• Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
• Execute analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
• Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
• Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
• Assist with monitoring and the control of laboratory supply and critical reagent inventories.
• Qualify as trainer for specified methods, provide training to less experienced staff.
• Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
• Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
• Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
• Identify areas to improve operational excellence by reducing non-value-added activities and increasing process efficiency.
• Perform other responsibilities as deemed necessary.

Skills

Quality mindset

Attention to detail

Strong communication

Time management

Education

Bachelor of Science degree

Tools

BINOCS

SAP

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

THIS A CONTRACT ROLE

***Shift: Wednesday – Saturday (Onsite 4 days), swing shift (1pm-11:30 pm) ***

Purpose

The Quality Control Analytical In-Process (QCA-IP) Analyst is responsible for performing analytical
test methods on in-process intermediates and varying stages of drug products under minimal
supervision and within cGMP guidelines, to support further manufacturing of commercial and
clinical therapeutics. This role will involve knowledge that includes but is not limited to the
following analyses and concepts: Protein determination by A280, Bradford, UV Absorbance,
Enzyme activity, HPLC/UPLC, and method validation.

CHARACTERISTICS

Functional activities may include: performing a wide variety of analytical assays, maintaining test
sample throughput, monitoring lab supplies, preparing reagents, contributing to process and
method validation studies, supporting investigations and equipment validation, and
brainstorming further development or improvement ideas for procedures.
Work assignments will vary by degree of complexity. Employee is expected to follow SOPs, make
appropriate decisions in daily activities with minimal needs for intervention, and be able to
recognize deviations from routine practices. Incumbent must accurately complete tasks on time
to achieve lab goals, meanwhile limiting GMP / procedural errors, and be capable of accepting
and incorporating feedback. Must also demonstrate the ability to both manage time and
prioritize routine work effectively.
Employee must be able to interpret results against defined criteria, begin to apply critical
thinking to routine work. He/she should demonstrate an ability to evaluate results against trend

QCA-IP Job Profile Analyst

reports, serve some degree of troubleshooting and capacity as trainer, and embrace an active
role in following up on atypical results or issues.
Communication of relevant information must be made to appropriate audiences, and
attendance of necessary team meetings with some participation in discussions is essential.
Employee should also be actively engaged in his/her role, exhibit frequent volunteerism as the
work schedule flow permits and maintain a positive attitude.

RESPONSIBILITIES

• 1. Timely facilitation of incoming sample receipt and accessioning flow, decipher batch
  assignments across all assay types in accordance with agreed upon best practices.
• 2. Execute analytical methods to facilitate in-process testing under applicable cGMP
  guidelines, as well as contribute to the prompt reporting of results to meet the required
  timetables of internal customers.
• 3. Evaluate completed assay validity, calculate and summarize results, analyze data per
  expected or specification ranges. Assist with the compilation and verification of trend
  analysis reports.
• 4. Perform and collaborate with co-workers to appropriately share general housekeeping
  activity assignments and ensure systems for laboratory maintenance are adequate for
  creating a consistent state of inspection readiness.
• 5. Assist with monitoring and the control of laboratory supply and critical reagent
  inventories.
• 6. Qualify as trainer for specified methods, provide training to less experienced staff.
• 7. Exhibit proactive communication upon occurrence of compliance risks and deviations
  from laboratory procedures, perform initiation of investigation records within required
  timeframes.
• 8. Provide input or assay support to the progression of test method validation,
  investigations, technical studies, and method transfer protocols.
• 9. Attend team huddles and department meetings, generate ideas for laboratory
  infrastructure improvements and method optimization.
• 10. Identify areas to improve operational excellence by reducing non-value-added activities
  and increasing process efficiency.
• 11. Perform other responsibilities as deemed necessary.

QUALIFICATIONS

• 1. Bachelor of Science degree.
• 2. 0-3 years of relevant laboratory experience; QC specific experience is preferred.
• 3. Experience with quality management systems, current Good Manufacturing Practices,
  and QC principles.
• 4. Demonstrated working knowledge with respect to certified functional activities.
• 5. Good documentation, written and verbal communication skills are essential.
• 6. Must possess the ability to perform most tasks with minimal supervision.
• 7. Computer literacy is required, with proficiency in Microsoft Word and Excel, and
  experience in Microsoft PowerPoint preferred.
• 8. Familiarity with BINOCS or similar scheduling systems is preferred.
• 9. Familiarity with SAP or similar enterprise systems is preferred.
• 10. Must have a quality service attitude and focus, exhibit flexibility and willingness to work
  additional hours to meet production or laboratory process requirements.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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