Quality Specialist II
Company: PDS Tech, Inc.
Location: Cambridge
Posted on: January 11, 2021
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Job Description:
PDS Tech is seeking candidates for a Quality Specialist II
position in Cambridge, MA.How will you make an impact?The Quality
Assurance Specialist II will support the quality systems team in
Cambridge, MA. The Specialist will be responsible for evaluating,
reviewing, and approving CAPAs or Change Controls. In this role,
they will support Compliance and Quality Assurance management in
maintaining and improving cGMP quality Systems.What will you do?*
Conduct QA assessments of product specific change controls, quality
issues, CAPA, GMP documentation and contributing to multiple
project teams as the quality decision maker* Reviews and approves
change controls for appropriateness, completeness and alignment
with quality, validation and regulatory expectations* Work with
functional groups across the site to review and approve quality and
technical documentation including: CAPAs, Action Notice (AN),
Change Control Requests (CCR), Documentation Change Requests (DCR),
effectiveness reviews as well as associated documentation in
support of Preventive/Corrective Maintenance, Metrology, Automation
Engineering and Validation.* Support third party audits, external
customers, and Agency inspections as needed and support internal
activities concerning any identified nonconformities* May perform
archiving duties in support of QA Document Control* Will perform
data migration from paper systems to new electronic data
systems.How will you get here?Education, Experience* Bachelor's
degree and 3 years of related work experience or Master's degree
and 1 year of work experience. * Preferred experience working in 2
or more functional areas* Minimum of 2 years in cGMP Quality
Control operations in a fast-paced production environmentKnowledge,
Skills, Abilities* Demonstrated ability collaborate across the
business.* Strong analytical and problem-solving skills; great
attention to detail and excellent decision-making process.*
Demonstrated ability to present ideas persuasively and negotiate
effectively* Excellent written and oral communication skills both
internal and external.PDS Tech, Inc. is an Equal Opportunity
Employer. All qualified applicants will receive consideration for
employment without regard to race, color, sex, sexual orientation,
gender identity, religion, national origin, disability, veteran
status, age, marital status, pregnancy, genetic information, or
other legally protected status.Founded in 1977, PDS Tech, Inc. is
one of the nation's premier specialty staffing firms with 31
offices nationwide. We offer a full range of benefits including:*
Health insurance* Paid holidays* Weekly payroll* Immediate 401(k)
eligibility* Completion Bonuses* Training* Please note availability
of benefits may vary by positionPDS specializes in Engineering and
IT arenas including Aerospace, Defense, Electronics,
Telecommunications, Automotive, and Energy just to name a few. Our
reputation, track record, and years of continuous growth reflect
the commitment to quality that our employees and clients experience
first-hand. To find out more about PDS, please visit
www.pdstech.com$$$ PDS pays for referrals! $$$
Keywords: PDS Tech, Inc., Cambridge , Quality Specialist II, Other , Cambridge, Massachusetts
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