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22 days old

Quality Engineer (Pharma and Validation)

Kelly Services
Albuquerque, NM 87190
As a Quality Engineering job is available with Kelly Engineering Services in Albuquerque, NM. A Bachelors degree in and 2+ years experience working in a biopharmaceutical or pharmaceutical environment.



Duties:




+ Reviews and approves key quality records as they related to products such as;

+ Site Validation Master Plan.

+ Validation protocols and reports per Change Control Processes.

+ High-risk CAPAs (i.e., Field Action, External Observations).

+ New or revised inspection plans and associated sampling strategies.

+ Where necessary, collaborate with PSC in failure investigation and corrective action planning for High-Risk CAPAs (i.e. Field Action, External Observations) involving products.



Coordinates review and approval of;




+ Non-routine rework in collaboration with other required functions such as Design Quality, Product Management, and Sustaining Engineering.

+ Use-as-Is Nonconformance Disposition in collaboration with other required functions such as Regulatory Affairs and Medical Affairs.

+ Supports Technical Assessments in collaboration with SC site compliance, Supplier Quality Compliance, and Product Management.

+ Partners with SC Quality Engineering, Medical Affairs, and R&D/PM in the development of Process Failure Mode Effects Analyses (pFMEAs) and corresponding Control Plans.

+ Supports SC Quality and Manufacturing Engineering on the resolution of quality issues impacting products and coordinates additional subject matter expert support needed from company.

+ Supports improvement plans to address below-target metrics and negative trends.

+ Serves as the Site Liaisons deputy.

+ Partners with SC on Recall Prevention and External Audit Readiness initiatives.

+ Responsible for communicating business related issues or opportunities to next management level

+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs other duties assigned as needed.



BASIC QUALIFICATIONS




+ Bachelors degree preferred. Equivalent education/experience may be accepted in lieu of degree.

+ Minimum of 3 -6 years related QA experience in a Pharmaceutical manufacturing environment required




+ Please Local Candidates Only and must be US Citizen or Permanent Resident (Green Card) to facilitate access to facilities



Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the submit now button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position angela.moreno@kellyengineering.com




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



Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.




**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.
Posted: 2019-12-27 Expires: 2020-01-27

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Quality Engineer (Pharma and Validation)

Kelly Services
Albuquerque, NM 87190

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