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manufacturing associate ii

Company: Randstad US
Location: Dublin
Posted on: January 15, 2022

Job Description:

manufacturing associate ii.

+ dublin , california

+ posted 4 days ago

with

randstad indeed

**job details**

summary

+ $24 - $27 per hour

+ contract

+ bachelor degree

+ industryprofessional, scientific, and technical services

+ reference39716

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job details

job summary:

As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!

This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.

location: Dublin, California

job type: Contract

salary: $24 - 27 per hour

work hours: 3 to 11

education: Bachelors

responsibilities:

+ Comply with Company Corporate and Divisional policies and procedures, ABL Plant procedures, and regulatory agencies regulations and requirements.

+ Provide technical assistance to the manufacturing areas (Inoculum, Fermentation, Capture, Purification, Buffer & Media Formulation, Weigh & Dispensing and Glass Wash & Autoclave).

+ Assist in the troubleshooting of the manufacturing equipment and process.

+ Investigate process and equipment exceptions and follow up CAPA implementation.

+ Revise SOPs and PCR and submit Change Requests (CR) for approval.

+ Develop and implement changes that will improve equipment performance and consequently product quality in the Bulk Drug Substance Manufacturing Areas (Upstream, Downstream and Central Services Areas) and reduce manufacturing costs.

+ Evaluate and implement new equipment technology.

+ Establish requirements and assist in the implementation of changes to the Process Control System.

+ Participate in the development and execution of validation protocols. Participate in the manufacturing personnel training.

+ Give direct support to the manufacturing process and trouble shootings.

+ Provide assistance to the Area Supervisor in the batch record audit process and discrepancies closures. Provide assistance during Regulatory Agencies Audits.

qualifications:

+ Bachelor Degree in Sciences (i.e.. Biology, Chemistry, Engineering).

+ Proven ability to effectively meet manufacturing goals by established dates in team setting.

+ Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, and EN46000), knowledge of corporate, local, state, and OSHA regulation.

+ Excellent verbal and written communication skills in both, English and Spanish.

+ Experience Requirements

+ At least five (5) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.

+ Previous experience in manufacturing processes of biotechnological drugs, aseptic operations, parenteral drugs, solutions preparation, and sterilization operations preferable.

+ Knowledge in manufacturing equipments troubleshooting.

+ Previous experience with Control Systems; Delta V and MES preferable.

skills: MS-WORD, MS-EXCEL, GMP (Good Manufacturing Practice), Manufacturing Operations

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Keywords: Randstad US, Dublin , manufacturing associate ii, Other , Dublin, California

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