Technical Operations Change Control Specialist - Boston, United States - DPS Group

DPS Group

Verified Company

Boston, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Arcadis DPS is looking for a Technical Operations Change Controls Specialist for a client in Boston, MA.

Location:
Boston, Massachusetts, United States

Employment Type:
Full-Time

Reference Code:
TSO824718MA

Date Posted: 15/May/2024

Years of Experience Req: 0 Years

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, scaleups, 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.
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. 58 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.
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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.
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Culture

Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, bestinpractice development, and pride in workmanship.

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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.

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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.

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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.

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Use of Technology

Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.

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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 e