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13 days old

Quality Assurance Associate II

Kelly Services
Palo Alto, CA 94301
Quality Assurance Associate, Palo Alto, CA



Full-time Direct Hire



Duties include:

Develop, draft, and compile documents of clinical protocols for the Investigational New Drug (IND) and Chemistry Manufacturing and Controls (CMC) sections for submissions to Food and Drug Administration (FDA), Institutional Review Board (IRB) etc.

Evaluate compliance of all completed manufacturing (batch records, forms, etc.) and quality control records (test/analytical results) to identify deviations. Review deviations and determine if batch record should be escalated for additional review or investigation.

Provide guidance to Product Development/Manufacturing (PD/MFG) and Quality Control (QC) to ensure compliance with all applicable regulations and assist in resolution of issues identified.

Evaluate and analyze the impact of new regulations to determine how to implement within unit and make recommendations based on findings for implementation.

Oversee Quality Assurance contract manufacturing activities to ensure required quality standards are maintained based on cGMP (current Good Manufacturing Practice) regulations.

Perform independent review of documentation during and post-execution of cGMP activities. Ensure all specifications are met and that applicable requirements are completed and acceptable.

Provide guidance and directives regarding remediation activities required to continue production. Continuously identify and manage issues to ensure quality control is maintained, compliant, and the issues have no impact to quality of product/process.

Ensure raw materials used for manufacturing and testing comply with cGMP requirements and ensure staff are trained as required.

Collaborate with (PD/MFG and QC) to resolved minor and major deviations and to execute continuous compliance with quality systems, internal SOPs (Standard Operations Procedures), and regulatory requirements. Actively participate in the mitigation of risks by identifying quality issues, determining corrective actions, minimizing reoccurrence, and evaluating quality impact.

Generate quality metrics including but not limited to deviation trends, CAPA effectiveness, EM excursions, product lot acceptance, confirmed OOS, product complaints rate, annual product review completion, per defined interval to ensure quality attributes are maintained.

Develop processes that enable routine execution and achievement of product/project timelines and contribute to completion of project milestone.

Participate in cGMP compliance audits of vendors, contract manufacturers, contract laboratories, and quality systems.

Ensure equipment qualification have been completed; preventive maintenance and calibration performed prior to due date.

* - Other duties may also be assigned




DESIRED QUALIFICATIONS:

Bachelors degree in life sciences (e.g. biology, chemistry, etc.).

Ability to effectively work in fast pace environment with cross functional groups involved in multiple projects and timelines.

Flexibility to support changing priorities while maintaining collaborative approach.

Able to work independently with some supervision.

3 to 5 years of cGMP experience.

Experience in product release, investigations and leading one or more of the following specialized areas: materials management, operations and/or quality systems.


EDUCATION & EXPERIENCE (REQUIRED):


Bachelors degree and three years relevant experience or an equivalent combination of education and relevant experience.


KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

Working knowledge of GMP/ ISO compliance and quality systems.

Working knowledge of federal, state and local regulations, GMP, IND, FDA, and CMC.

Demonstrated ability of problem-detection and problem-resolution skills.

Demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.

Must possess excellent verbal and written communication skills








**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-11-29 Expires: 2019-12-30

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Quality Assurance Associate II

Kelly Services
Palo Alto, CA 94301

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