Quality Assurance Specialist (Risk Assessments)
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.
Location:
Boston, Massachusetts, United States
Employment Type:
Full-Time
Reference Code:
TSO824679MA
Date Posted:
10/Apr/2024
Years of Experience Req.:
0 Years
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.
- Continuous Learning –Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.
- Culture - Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.
- Customer Services – Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.
- Planning and Organizing – Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.
- Teamwork – Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others’ views. Gives and welcomes feedback. Puts success of team above own interests.
- Use of Technology – Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.
- Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.
- Mathematical Ability - Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
- Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.
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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