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Quality Assurance Associate I

Kelly Services


Location:
Palo Alto, CA
Date:
04/19/2018
2018-04-192018-05-19
Job Code:
US15TPBC_BH1393982
Categories:
  • Government
  • Regulatory Affairs
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Job Details

Job Title Quality Assurance Associate I

Jobid US15TPBC_BH1393982

Location: Palo Alto, CA, 94301, USA

Description **Quality Assurance Associate I**

**Location: Palo Alto, CA**

**Direct Hire Opportunity**

**Description:**

Kelly Scientific is seeking a Clinical Manufacturing Quality Assurance Associate I to develop and maintain effective quality system in accordance with regulations (GMP) and applicable guidance for our client’s facility. The candidate possess strong technical quality experience who can promote quality and support best quality assurance practices.


**Duties include** :


+ Assist with developing, drafting, maintaining, and compiling of process related documents to support cGMP (current Good Manufacturing Practice) clinical manufacturing. Support generating procedures by following set guidelines and provide suggestions for issues found in documentation processes.
+ Generate and issue documents (e.g. batch records, labels, forms associated with clinical manufacturing)
+ Provide Regulatory Affairs support needed to enable completion of IND submissions (e.g. Label generation, Quality Systems (QS) documents, clarification of QS processes, document retrieval, etc.).
+ Identify, classify, and report deviations associated with processes and/or protocols and provide issue resolutions and process improvements to Product Development/ Manufacturing (PD/MFG) and Quality Control.
+ Review batch records and product dispositions to ensure process is performed per procedure guidelines.
+ Assist with the development and maintenance of Standard Operating Procedure (SOPs), batch records, raw materials specifications, certificate of analysis, training records etc.
+ Perform quality assurance activities including but not limited to executed or new document review, documents revision, deviation initiation/review, change control initiation, materials management activities, CAPA initiation/tracking, line clearance, material kitting, etc.
+ Perform real-time observation of activities including proper and timely documentation.
+ Provide resolution of quality assurance issues/documentation in compliance with LCGM policies, cGMP, and Institutional Review Board (IRB) protocols. Report quality issues internally and to appropriate departments.
+ Participate in regulatory, quality and compliance meetings to represent Quality Assurance.
+ Responsible for compiling, organizing and storing all documentation related to FDA and cGMP regulations including developing and maintaining a system for storing documents.
+ Provide support for cGMP compliance audits of vendors, contract manufacturers, contract laboratories and quality systems by preparing and reviewing all documents, tracking timelines, and handling back office operations during site visits.
* - Other duties may also be assigned
**Qualifications**

**DESIRED QUALIFICATIONS:**


+ Must be able to work effectively in a fast-paced environment with cross-functional groups involved in multiple projects and timelines.
+ Must be flexible in supporting changing priorities while maintaining a collaborative approach.
+ Must be able to work independently with some supervision.
+ Bachelor’s degree in Biology, Chemistry, or Life Science preferred.
**EDUCATION & EXPERIENCE (REQUIRED):**

**Bachelor’s degree and one year relevant experience or an equivalent combination of education and relevant experience.**

**KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):**


+ Knowledge of GMP/ ISO compliance, and quality systems.
+ Applicable or related experience in a quality-related work in a cell therapy/biotech manufacturing setting
+ Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
+ Experience with office software and database applications.
+ Excellent inter-personal skills and customer service focus.
+ Ability to communicate effectively both orally and in writing
**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

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

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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