-
Senior Quality Assurance Specialist
10 hours ago
DPS Group Global Boston, United StatesSummary · DPS Group is seeking a qualified Senior Quality Assurance Operations professional to perform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA client site. · Responsibilities · Perform batch disposition, batch record re ...
-
Senior Specialist, Quality Assurance
1 day ago
PepGen Boston, United StatesSr Specialist, Quality Assurance · Position Summary · The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site. Routine activities including review and approval of master batc ...
-
Senior Specialist, Quality Assurance
6 days ago
OSI Boston, United StatesSr Specialist, Quality Assurance · Position Summary · The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site. Routine activities including review and approval of master batch ...
-
Quality Assurance Sr. Specialist
1 week ago
Katalyst Healthcares And Life Sciences Boston, United States:seeking a Quality Assurance Sr. Specialist for real time on the floor quality oversight and lot disposition of Small Molecule GMP manufacturing facility at Moderna Inc. This position will be based in our cGMP Small Molecule Manufacturing site in Cambridge, MA.The individual in t ...
-
Quality Assurance Senior Specialist
2 days ago
Fagron GmbH & CO. KG Boston, United StatesOver de functie · The Quality Assurance Senior Specialist is an experienced professional level position responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition. Ensures that proper controls are followed and maintain ...
-
Quality Assurance Senior Specialist
4 days ago
Fagron Sterile Services Boston, United StatesAbout the job The Quality Assurance Senior Specialist is an experienced professional level position responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition. Ensures that proper controls are followed and maintained du ...
-
Quality Assurance Senior Specialist
3 days ago
Vertex Pharmaceuticals Boston, United StatesJob Description · The Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Sr. Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This pos ...
-
Senior Quality Assurance Specialist
1 week ago
Gardner Resources Consulting Boston, United StatesOur Pharma client, located in Boston, MA, is currently searching for a Senior Quality Assurance Contractor to help maintain quality systems with a focus on GMP Compliance.The Senior QA Contractor will assist with batch record review and will provide a thorough review and analysis ...
-
Senior Quality Assurance Specialist
6 days ago
Gardner Resources Consulting Boston, United StatesOur Pharma client, located in Boston, MA, is currently searching for a Senior Quality Assurance Contractor to help maintain quality systems with a focus on GMP Compliance. · The Senior QA Contractor will assist with batch record review and will provide a thorough review and anal ...
-
Quality Assurance Specialist
3 weeks ago
ezCater Boston, United StatesezCater is the leading food for work technology company in the US, connecting anyone who needs food for their workplace to over 100,000 restaurants nationwide. For workplaces, ezCater provides flexible and scalable solutions for everything from recurring employee meals to one-off ...
-
Commercial GMP Quality Assurance Specialist
3 weeks ago
Vertex Pharmaceuticals Boston, United StatesJob Description: · JOB DESCRIPTION: · Sound understanding of GMP principles and their application to product quality and compliance, supporting commercial paper-based Executed Batch Record (EBR) and disposition of Drug Substance (DS)/ Active Pharmaceutical Ingredient (API), Sp ...
-
Quality Assurance Specialist
2 weeks ago
Vertex Pharmaceuticals Boston, United StatesJob Description: · We are looking for an individual to image quality documents. Training will be provided, no prerequisite experience is required. · Perfect candidate will have a detail-oriented skillset and a basic understanding of technology. · We will require 40 hours of wo ...
-
Quality Assurance Specialist
3 weeks ago
Katalyst Healthcares and Life Sciences Boston, United StatesResponsibilities: Quality Assurance: Assist in the implementation and maintenance of quality assurance programs for cell therapy manufacturing activities. Batch Record Review: Review and analyze batch records for adherence to Good Manufacturing Practices (GMP) and internal qualit ...
-
CT Quality Assurance Specialist
2 weeks ago
Brigham & Women's Hospital - Brigham Health Boston, United StatesReporting to the Assistant Clinical Director (ACD), of CT the Quality Assurance Specialist facilitates the CT Quality Assurance program and provides appropriate education to the staff which includes assessing, planning, implementing, and evaluating b Quality Assurance, Assurance, ...
-
Technical Specialist, HLA
5 days ago
Brine Group Staffing Solutions Boston, United StatesTechnical Specialist, HLA · Location: Boston Teaching Hospital · Day shift. · No weekends and no holidays. · Salary range: $40/hr – high $50's/hr. · The Histocompatibility (HLA) Lab Technical Specialist is a key resource in the HLA lab. The individual in this position reports to ...
-
QA/QC Superintendent
2 weeks ago
Futura Energy Group Boston, United StatesWe are delighted to be partnered with a renewable energy company that is looking for a Construction Quality Specialist to join its construction projects team. · You will be responsible for overseeing and coordinating all quality inspection activities and will coordinate with cont ...
-
Sr. Director of Regulatory Affairs
3 weeks ago
Mantell Associates Boston, United StatesMantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for people with solid tumors/lung cancer and rare endocrine diseases, who are searching for a Director / Senior Director of Regulatory Affairs. · Director of Regulatory ...
-
Scientist, Discovery
2 weeks ago
Third Rock Ventures Boston, United StatesA stealth mode Third Rock Ventures start up is seeking a talented scientist to join the Discovery & Innovation group. The Scientist will be responsible for identifying and driving novel programs for patients suffering from autoantibody-driven diseases. The ideal candidate is an e ...
-
Regulatory Documentation Specialist
2 weeks ago
Digital Prospectors Boston, United StatesPosition: Regulatory Documentation Specialist · Location: Boston, MA (Onsite) · Length: 6+ months · Job Description: · Our client is seeking a Regulatory Documentation Specialist who will be responsible for overseeing, organizing, and preparing regulatory documentation essential ...
-
Eliot Community Human Services Boston, United States$3000 Sign on Bonus · The new Flexible Support Services initiative is an innovative model of care that includes funding to address many barriers to long term sustainable housing and recovery. The successful candidate will have unwavering compassion, an open mind in terms of path ...
Quality Assurance Specialist - Boston, United States - DPS Group Global
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
SummaryADPS 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.
#LI-NH1
#J-18808-Ljbffr