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23 days old

Quality Assurance Specialist (GxP)

Kelly Services
Cambridge, MA 02238
Kelly Services is currently recruiting for **Quality Assurance Specialist** for our client, a multinational pharmaceutical and biopharmaceutical company.


If this position may be interested to you, please email me back at somp767@kellyservices.com (with your most up to date resume in word format) and advise the best time and number at which you can be reached.


**Job Title: Quality Assurance Specialist**

**Location: Cambridge, MA (Position will start from working from home and eventually transition back to office in Cambridge) (Will be onsite 1 hr/week during COVID)**

**Type: Contract (W2)**

**Length: Indefinite (long term)**

**Pay Rate $65 - $78 per hour**


Candidate must be eligible for direct W2 contract without employment sponsorship.


**Notes from the hiring manager**


+ Quality, R&D role, GxP systems

+ Quality oversight needed

+ Global systems support

+ Software development lifecycle knowledge helpful

+ Working in Agile environment

+ Infrastructure qualifications, systems validation and implementation knowledge

+ Lab equipment oversight, computerized systems overview

+ Not a validation lead role, but validation experience very helpful

+ Will be onsite 1 hr/week during COVID


**Job Descriptions:**


Under the direction of the Head, Data Systems, R&D Quality Assurance and Compliance, this role is responsible for providing support in software quality assurance overseeing of systems validation activities related to systems utilized by the Research & Development team. You will provide compliance leadership and direction to business and project teams in Software Development Life Cycle / System Validation (CSV)/Lab Systems/Lab Equipment/Infrastructure Qualification standards and practices.


This is accomplished by:


+ Providing professional expertise, guidance and strong leadership in Computer System Validation and applicable regulatory requirements (21 CFR Part 11/Annex 11/GAMP 5) as applicable to the Global R&D GxP requirements (GLP, GCP, GPvP, GDP) to proactively identify compliance issues/risks in all functions within the organization and its external partners.

+ Participating in the delivery of system solutions by overseeing/reviewing SDLC/CSV/Qualification activities.

+ Guiding development of validation/qualification/migration/verification strategies for software (including lab), data, mobility, hardware, infrastructure/components and/or business processes prior to release into a live environment per company procedure(s).

+ Overseeing execution of validation/qualification/verification/migration strategies per company procedure(s).

+ Providing validation/verification/qualification guidance to stake holders as necessary.

+ Managing relationships with key customers and stake holders to ensure oversight that the total validated/verified/qualified solution delivered meets/exceeds expectations.

+ Ensuring SDLC/CSV/Qualification activities are conducted in a compliant and timely manner.


**Accountabilities:**


+ Subject Matter Expert on SDLC/Qualification procedures and regulations and able to provide guidance to IT and/or Business.

+ Participate on cross functional teams to oversee validation/verification, implementation, and maintain regulated (Example: GxP, JSOX etc.) systems across the Organization.

+ Oversee the validation/verification/qualification strategy development by working with the validation team.

+ Work with project teams offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.

+ Ensure the project testing scope is met per specified agreement and/or scope change.

+ Understands the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression.


**Job Requirements:**


+ Bachelors Degree in Life Science or Computer Science

+ Minimum 10 years of software quality assurance experience with lead experience.

+ Broad knowledge of software development life cycle.

+ Must have pharmaceutical industry experience and familiar with GxP.

+ Demonstrated experience leading cross functional teams advising on compliance related matters and influencing Senior Leaders.

+ Possess the following qualifications is added advantage:

+ American Society for Quality (ASQ)

+ Certified Software Quality Engineer (CSQE)

+ Quality Assurance Institute (QAI)

+ Ability to fly to travel regionally and globally for meeting if required.


Soma Patanaik

IT Recruiter

somp767@kellyservices.com

Work (630) 270 7630

Web kellyservices.com


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


By partnering with Kelly Technology, youll have direct connections to top companies around the globegiving you the chance to put your tech skills to work on some of todays most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. Were here to help you gain experience, keep learning, and move your career forward.


**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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-03-31 Expires: 2021-05-01

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Quality Assurance Specialist (GxP)

Kelly Services
Cambridge, MA 02238

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