13 days old

Quality Validation Engineer

Kelly Services
Cambridge, MA 02238
**Quality Validation Engineer Cambridge, MA**

_Full-time, Contract position 12+ months_

_Pay - $60-$70/hr_

_Shift Hours: 8-5pm_

_100% onsite_

**Key Objectives of the role:**

+ Supports the manufacturing process owners and other functional area managers as a Quality Assurance Validation subject matter expert.

+ Provides Quality support for complex cross-functional investigations in a variety of subject matter area to determine root cause and corrective actions.

+ Develops improvements to the Quality Management System to enhance compliance with regulatory requirements.

+ QA oversight for investigations to deviations and non-conformances identifying root cause, corrective/preventive actions, and effectiveness of actions taken.

+ Reviews and approves quality records, validation protocols, standard operating procedures, Work Orders, Preventative Maintenance activities, Calibration activities, changes to procedures and processes to ensure compliance with required standards.

+ Contributes expert process knowledge for product and process design and validation teams.

+ Works directly with customers (internal, external, suppliers) on complex critical to quality issues.

+ Quality oversight for cross-functional team projects (R&D, Mfg, Vendors, etc). **Minimum Qualifications (must have):**

+ Bachelors degree in engineering or Science Discipline with minimum 5 years of experience or High School Diploma with 8 years of experience within the Pharmaceutical Industry supporting the manufacture of Regulated Product.

+ Advanced knowledge of Quality Engineering principles and practices in a FDA Regulated Environment.

+ Proficient in team building and leading product quality investigations.

+ Technical report documentation and authoring procedures.

+ Analytical Instrument Validation,

+ Analytical Method Validation,

+ Process Validation


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-19 Expires: 2022-10-20

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Quality Validation Engineer

Kelly Services
Cambridge, MA 02238

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