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Formulation Specialist I
Company: Cepheid
Location: Lodi, CA
Employment Type: Full Time
Date Posted: 10/07/2021
Expire Date: 11/06/2021
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Quality Control, Research & Development
Job Description
Formulation Specialist I

POSITION SUMMARY:

Senior level position responsible for supporting the Bulk Buffer, Reagents and Bead production laboratories by following good documentation practices (cGDP) and relevant standard operating procedures (SOPs). Complete assigned tasks and ensure all activities are compliant with the companys quality, safety and departmental policies and standards. Has advanced and specialized expertise in an analytical/scientific method or operational process. Works autonomously within established procedures and practices. Has developed advanced specialized expertise within an analytical/scientific area to perform the most complex work. Completes assignments and facilitates the work activities of others; may coordinate work beyond own area

ESSENTIAL JOB RESPONSIBILITIES:

  • Work safely with hazardous chemicals and follow all safety policies fostering a safe work environment
  • Immediately report all safety concerns including injuries and safety suggestions
  • Exercises judgment, based on previous experience, practices and precedents, to identify and solve problems that arise with little or no precedent
  • Works within defined processes and procedures or methodologies and may help determine the appropriate approach for new assignments
  • Exchanges ideas and information effectively; uses tact and diplomacy when dealing with others
  • Responsible for: liquid bead formulation, bulk buffer formulation, bead dropping using a beadulator, loading and unloading beads from the lyophilizer, sieving of beads, aliquoting and labeling of dyes and grease
  • Performs pH, Moisture, Conductivity and Density testing
  • Perform accurate real time documentation to ensure right first time (RFT) operations
  • Perform verification and review of peer activities
  • Train others on lab responsibilities
  • Provide guidance and support to more junior team members
  • Monitor equipment and inform leads or management of any issues
  • Maintain laboratory housekeeping including reagent and equipment inventory levels
  • Recognize issues and defects and complete necessary documentation and escalate accordingly
  • Recommend and implement improvement ideas in the lab that will positively affect production efficiency, Quality and Safety
  • Assist other department in qualification of new methods and instruments
  • Trouble shoot equipment and assay failures
  • Suggest and assist in SOP revisions
  • Assists management with audit activities
  • Manages projects within the department
  • Has additional assigned responsibilities to assist management

TRAINING RESPONSIBILITIES:

  • Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience:

  • Bachelors degree with 0-2 years of related work experience.

Knowledge and skills:

  • Must be able to follow cGMP and cGLPs, FDA and ISO standards
  • Must be able to follow direction, able to understand SOPs and demonstrate understanding through speech and/or written form
  • Proficiency in computer systems such as Word, Excel, SAP, MES and e-mail
  • Has a good understanding of how related teams coordinate their efforts and resources to achieve objectives

Physical requirements/abilities:

  • Must be able to lift 25 Lb Must be able to stand for several hours. Work may involve repetitive arm/wrist motions
  • Ability to transport heavy materials up to 400 Lb with the appropriate machine or equipment assist
  • Ability to work in controlled environment

PREFERRED REQUIREMENTS:

  • Bachelors Degree in Life Sciences
  • Prior experience working in a GMP environment and pharmaceutical industry
  • Experience using analytical scales, Lyophilizer, Molecular assays, working with hazardous chemicals
  • Flexibility with the work schedule including modified shift times, overtime and weekends
  • Equipment validation including IQ/OQ/PQ
  • Assay development and transfer

When you join us, youll also be joining Danahers global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, youll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

If youve ever wondered whats within you, theres no better time to find out.

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Company Name: Cepheid
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