DPS Engineering Boston , MA 02298
Posted 3 weeks ago
Summary
ADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk assessments and obtain cross-functional endorsement/approval by established deadlines.
Responsibilities
Experienced in facilitating Quality risk assessments
Good technical writer and write the documents that support the risk assessment
Participate in Risk Assessment activities, applying Phase appropriate guidance for engineering deliverables for production
support leading and owning risk assessments in support of change controls and deviations.
holding stakeholder meetings to progress risk assessments and obtain cross-functional endorsement/approval by established deadlines
Provide oversight and guidance for development of proactive approaches for the Continuous Improvement Plan (CIP) items
Provide expertise for CAPA and Quality Event investigation to progress through the systems
Participate in preparation activities for partner audits and site readiness for inspections
Provide guidance and input for Quality Projects
Perform Phase appropriate assessments
Participate in critical investigations
Other duties as assigned
Skills and Qualifications
Prior GMP experience (at least 3-5yrs), with preference for quality/quality risk management experience.
Excellent judgment and ability to communicate complex issues in an understandable way
Outstanding communication skills (verbal and written)
Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
Additional
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The Company
DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
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DPS Engineering