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28 days old

Quality Assurance Associate III (Mountain View, CA)

Kelly Services
Mountain View, CA 94035
**Quality Assurance III**


Mountain View, CA


Temp maternity leave coverage for a QA3 leaving in early September


Possible temp-hire


Responsible for performing Quality Assurance activities with minimal supervision in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports. This role will review QC data; perform material and final product releases; review of Deviations as well as assist Quality management with department needs. He/she will exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Interfaces directly with client (acts as SPOC for Quality) and cross functional teams Provides resolutions pertaining to quality for project related issues


**Essential Functions and Responsibilities**


+ Independently prioritizes, schedules, and manages multiple projects and resources (team)

+ Review and approve validation and qualification documents for compliance with cGMP

+ Maintain cGMP compliance for all aspects of clinical and commercial manufacturing

+ Follow Standard Operating Procedures for Global Quality (pre-clinical, clinical, commercial) functions Maintain cGMP compliance for all aspects of clinical and commercial manufacturing

+ Assist gathering information for internal and external (e.g. cGMP, client, regulatory agencies) audits.

+ Direct batch record review activities to ensure release of data to clients within prescribed timelines and in compliance with applicable cGMP requirements and client Quality Agreements (once team member is sufficiently trained)

+ Train and mentor new associates

+ Facilitates internal training on quality assurance requirements, processes, and procedures.

+ Provides technical expertise to the client services team on tech transfer activities.

+ Provides supportive documents to investigators and/or compliance team.

+ Conducts final verification of batch records prior to archiving; sends records to document control

+ Review of executed APS reports/ batch records.

+ Draft SOPs, WIs, and Forms for revision.

+ Supports QA teams with continuous improvements initiatives to enforce quality culture.

+ Initiate and approve non-critical change control as required.

+ Support walk thru in preparation for internal and external (e.g. cGMP, client, regulatory agencies) audits

+ Other duties as assigned.


**Competencies/Candidate Profile**


+ Detail-oriented and organized

+ Analytical and problem-solving skills

+ Good written and oral communication skills

+ Ability to multi-task and be adaptable

+ Flexible and able to adapt to company growth and evolving responsibilities

+ Ability to work independently and with a team

+ Strong project management and organization skills


**Supervisory Responsibilities**


+ Indirectly supervises QA Associates I and Il within the Quality Assurance department.

+ Team lead for 2-3 Quality Associates I & Il


**Qualifications**


+ Bachelor of Science in biological sciences or other relevant field of study

+ Minimum 5 years' experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics.

+ Working knowledge and technical understanding of aseptic manufacture of biologics

+ 7 years of cGMP experience

+ Experience in authoring, reviewing, and /or approving cGMP related documents (validation/qualification reports, SOPS. Etc.

+ Experience in both clinical and commercial manufacturing is preferred.

+ Experience in organizing teams for effective and timely completion of projects.

+ Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.

+ Experience participating in or hosting health authority inspections and/or client audits.

+ Relevant computer skills (Microsoft Office, Outlook)

+ Understanding of quality system applications


**Minimum Required Training to Be Completed within the first 90 Days of hire**


+ GMP training

+ SOP and WI Training

+ Safety Training


**Working Environment**


+ This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

+ Seating is mixed and includes open space seating, cubicle, and office space.

+ Noise level is moderate.

+ Must have the ability to work in a team-oriented environment and with clients

+ Must be able to work during the weekend, holidays and as required by the company May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids

+ Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc.


**Physical Requirements**


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.


+ The employee is frequently required to lift and/or move up to 30 pounds.

+ Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear, balance; stoop, kneel, or crouch.

+ Environment may require gowning, hair net, safety glasses, gloves, and foot coverings


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-08-25 Expires: 2021-09-25

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Quality Assurance Associate III (Mountain View, CA)

Kelly Services
Mountain View, CA 94035

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