- Assesses own strengths and weaknesses.
- Supports a culture of excellence.
- Displays courtesy and sensitivity.
- Prioritizes and Plans work activities.
- Balances team and individual responsibilities.
- Demonstrates required skills.
- Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
- Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
-
Inventory Control Specialist
6 days ago
New England Building Supply Boston, United StatesThe Inventory Control Specialist will be responsible for maintaining an accurate inventory through regular cycle counts, spot checks and following process for annual inventory, investigating and monitoring issues as needed. · Duties/Responsibilities: Tracks issues and identifies ...
-
Project Controls Specialist
2 weeks ago
PTS Advance Boston, United StatesResponsibilities: · Lead project control processes with the internal project management team to execute project deliverables within budget and schedule. · Plans and tracking project scope for aviation clients, · Ensure project set-up in the Enterprise Planning & Controls software ...
-
Inventory Control Specialist
6 days ago
New England Building Supply Boston, United StatesThe Inventory Control Specialist will be responsible for maintaining an accurate inventory through regular cycle counts, spot checks and following process for annual inventory, investigating and monitoring issues as needed. · Duties/Responsibilities: · Tracks issues and identifie ...
-
Technical Operations Change Control Specialist
4 weeks ago
DPS Group Global Boston, United StatesSummary · Arcadis DPS is looking for a Technical Operations Change Controls Specialist for a client in Boston, MA. · Key Responsibilities · Initiate the change control process. Gather information from the requesting department, bring information to the change control committee fo ...
-
Traction Corrosion Control Specialist
5 days ago
Hdr Boston, United StatesAbout UsAt HDR, we specialize in engineering, architecture, environmental and construction services. While we are most well-known for adding beauty and structure to communities through high-performance buildings and smart infrastructure, we provide much more than that. We create ...
-
Quality Control Validation Specialist
3 weeks ago
ICONMA Boston, United StatesMaster's Degree is required (A Bachelor's degree may be considered for candidates with at least 5 years of research experience). · Minimum 3 years of clinical research, public health research experience or research working with high-risk patient populations. · Prefer candidates t ...
-
BOS Operations Control Center Specialist
6 hours ago
Swissport International AG Boston, United StatesOverview: · Are you ready to take flight in a dynamic and fast-paced aviation industry? As a global leader in aviation services, Swissport provides Ground Handling, Cargo Handling, and Passenger Services to over 300 million passengers annually. Our mission is simple To provide t ...
-
Access Control Specialist
3 weeks ago
Northeastern University Boston, United StatesAccess Control Specialist · About the Opportunity · This job description is intended to describe the general nature and level of work being performed by people assigned to this classification. It is not intended to be construed as an exhaustive list of all responsibilities, dut ...
-
Project Controls Specialist
1 week ago
Pts Advance Boston, United StatesResponsibilities:Lead project control processes with the internal project management team to execute project deliverables within budget and schedule.Plans and tracking project scope for aviation clients,Ensure project set-up in the Enterprise Planning & Controls software.Develop, ...
-
Traction Corrosion Control Specialist
2 weeks ago
HDR Boston, United StatesAbout Us · At HDR, we specialize in engineering, architecture, environmental and construction services. While we are most well-known for adding beauty and structure to communities through high-performance buildings and smart infrastructure, we provide much more than that. We cre ...
-
Traction Corrosion Control Specialist
2 weeks ago
HDR Boston, United StatesAbout Us · At HDR, we specialize in engineering, architecture, environmental and construction services. While we are most well-known for adding beauty and structure to communities through high-performance buildings and smart infrastructure, we provide much more than that. We cre ...
-
Quality Control Validation Specialist
3 weeks ago
ICONMA Boston, United StatesMaster's Degree is required (A Bachelor's degree may be considered for candidates with at least 5 years of research experience).Minimum 3 years of clinical research, public health research experience or research working with high-risk patient populations.Prefer candidates that ha ...
-
BOS Operations Control Center Specialist
4 weeks ago
Swissport International AG Boston, United StatesOverview · Are you ready to take flight in a dynamic and fast-paced aviation industry? As a global leader in aviation services, Swissport provides Ground Handling, Cargo Handling, and Passenger Services to over 300 million passengers annually. Our mission is simple - "To provide ...
-
Quality Control Compliance Specialist
3 weeks ago
PaleoValley Erie, United StatesSalary Range: $55,000 to $60,000 per year · Benefit Eligible: Yes, includes health insurance (medical, dental, vision) along with paid time off and a 401k with company match · Location: Remote within the US, open to candidates residing in the following states: AZ, CA, CO, FL, I ...
-
Quality Control Compliance Specialist
3 weeks ago
Paleovalley Erie, United StatesJob Description · Job DescriptionSalary Range: $55,000 to $60,000 per year · Benefit Eligible: Yes, includes health insurance (medical, dental, vision) along with paid time off and a 401k with company match · Location: Remote within the US, open to candidates residing in the foll ...
-
Information Technology Audit Manager
3 days ago
Broadgate Boston, United StatesIT Audit Manager · Responsibilities: · • Analyze business processes, procedures, and risks while evaluating internal controls. · • Effectively communicate with the Technology team and liaisons to manage expectations and ensure cooperation to achieve objectives. · • Develop and ...
-
Records Clerk
3 weeks ago
Akkodis Boston, United StatesRecords Specialist · Boston, MA (Onsite) · 3+ Months contract · Pay rate $17/hr - $19/hr · • Top 3 Required Skills: Records Experience, law firm/office experience, computer skills, able to do physical demands of job (lift boxes, clear file rooms, push carts,) · Provide maintenanc ...
-
QA/QC Superintendent
1 week 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 ...
-
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 ...
-
Director, Data Management
3 weeks ago
Curate Partners Boston, United StatesThe Director, Data Management & Analytics will help lead the transformation of our firm's core data infrastructure, using the Microsoft data stack on prem and in Azure. This hands-on leader will manage multiple team leads and staff contributors along a transformation path that se ...
Technical Operations Change Control Specialist - Boston, United States - DPS Group LLC
Description
Summary Arcadis DPS is looking for a Technical Operations Change Controls Specialist for a client in Boston, MA. Responsibilities Initiate the change control process.Gather information from the requesting department, bring information to the change control committee for endorsement, initiate the change control record in eQMS describing the change and the justification, drive the completion of the assessments, drive the agreement to the tasks, follow up on the completion of the tasks, submit the required documentation to close out the change control Work with technical SMEs (Regulatory, Engineering and Facilities, Manufacturing Science and Technology, Process Development, Supply Chain, Validation) to ensure the appropriate stakeholders are involved in the assessment of the change control and completion of the tasks Ensures the change controls are written to the best standards, with appropriate detail for review by regulatory agencies during audits Scope of change controls includes but not limited to:
Introduction of new process equipment, changes to existing process equipment, technical transfer of new process from Process Development to Manufacturing, tech transfer between manufacturing sites, changes to existing process, scale-ups, changes to Raw Materials, introduction of new programs/strategies.
Present change controls in the change control review board (CCRB) forum. Verify the impact of the change on regulatory filings. Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across CMC.Negotiate with QA partners:
discuss requirements, ensure the documentation is completed appropriately for closure, etc. Establish and manage the timeline for completion of the tasks. Follow up with the task owners to ensure that the change control does not become overdue. Escalate any risks or issues encountered during the execution of the change control Skills and Qualifications Approx. 5-8 years in a GMP environment in biotech/pharmaceuticals.
Preferably as a manufacturing specialist, MSAT/PD, process engineering, or QA specialist Experience writing change controls for biotech (biologics preferred) in an electronic Quality Management System such as Veeva or Trackwise Experience with tech transfer process.
Understands the different purposes and cGMP requirements for pilot runs, engineering runs, PQ runs etc. Excellent written skills. Can write clearly and effectively without requiring major corrections or oversight.Ability to convey complex processes in straightforward language Ability to read and interpret complex technical documents, such as experimental protocols and reports, manufacturing batch records, and regulatory filings Strong sense of ownership.
Role requires following up with stakeholders to ensure assessments and tasks have been completed. Problem solving and conflict resolution skills. Experience removing roadblocks and facilitating solutions. 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 LearningThe 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
