Website Lenox Executive Search
12+ month onsite CONTRACT role with strong potential to extend and/or convert to Permanent. Must have 5+ years Change Control experience in a GMP environment.
Lenox Executive Search is seeking an experienced Technical Operations Change Control Specialist to fill a Temp-to-Perm role with a global pharmaceutical company in Boston, MA. Must have experience writing change controls for biotech (biologics preferred) in an electronic Quality Management System such as Veeva or Trackwise.
REQUIREMENTS for the Technical Operations Change Control Specialist:
- 5+ years in a GMP environment in biotech/pharmaceuticals. Preferably as a manufacturing specialist, process engineering, or QA specialist
- Experience writing change controls for biotech (biologics preferred) in an electronic Quality Management System such as Veeva or Trackwise. Write change controls and follow up with next steps
- Needs to have GMP manufacturing experience, not just R&D – upstream and downstream processes
- Experience with tech transfer process. Understands the different purposes and cGMP requirements for pilot runs, engineering runs, PQ runs etc.
- Some experience setting up new sites, labs or cleanroom preferred
- Excellent written skills. Can write clearly and effectively without requiring major corrections or oversight (no grammatical errors). 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, facilitating solutions and driving alignment.
- Reviewing documents going to for regulatory filings
- Act as Mini project manager
RESPONSIBILITIES of the Technical Operations Change Control Specialist:
- 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 and the tasks, follow up on task completion, submit 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
- Ensure the change controls are written with appropriate detail for review by regulatory agencies
- 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,
- Verify the impact of the change on regulatory filings
- Negotiate with QA partners and obtain alignment on requirements
- Develop 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
Job Type: Contract
Salary: $65.00 – $75.00 per hour
- Monday to Friday
Ability to commute/relocate:
- Boston, MA: Reliably commute or planning to relocate before starting work (Required)
- Are you vaccinated?
- Change Control in GMP manufacturing: 5 years (Preferred)
- Tech Transfer Process: 5 years (Preferred)
- Veeva or Trackwise: 5 years (Preferred)
- Manufacturing batch records: 5 years (Preferred)