Job Title: Technical Writer/Operations Excellence
Job Location: Rockville, MD
Job Duration: 6 months ( Temp to Hire)
Job Location: Rockville, MD
Job Duration: 6 months ( Temp to Hire)
Pay rate: $29.50/hr on w2
Job Description:
- This role sits at the intersection of operational excellence, quality, training & development, and MSAT supporting efficient, compliant, and ever improving operations.
- The ideal candidate will have a strong understanding of cGMP compliance, quality event investigation, lean production methodologies, and process technology to drive reliability in operations.
Key Responsibilities and Duties:
- Process Improvement & Optimization
- Identify and implement continuous improvement projects using Lean methodologies to improve and stabilize yield, efficiency, and process success. Partner with MS&T and Process Development to monitor process performance to identify datadriven solutions and enhancements.
- Support technology transfer, process scale-up, and process validation to ensure smooth transitions into manufacturing.
- Partner with MS&T and Engineering to optimize equipment utilization, automation strategies, and data analytics for real time adjustments and support.
- Compliance & Manufacturing Support
- Conduct timely batch record reviews and deviation investigations, ensuring long term resolution of documentation/instructional issues.
- Lead root cause analysis and corrective/preventive action (CAPA) for process deviations, nonconformances, and quality issues.
- Work close with Quality and Manufacturing teams to ensure documentation supports data integrity & good documentation practices (GDP) incompliance with FDA, EMA, guidelines.
- Training and Documentation Management
- Develop and maintain SOPs, training materials, and documentation systems for manufacturing compliance and process improvements.
- Partner with MS&T and Training to conduct training programs for manufacturing staff to ensureadherence to cGMP, process guidelines, and quality requirements.
- Work cross-functionally to ensure employees remain qualified and up to date on process and compliance expectations.
Qualifications:
- Bachelor s degree in relevant Science or Engineering discipline preferred. (BS/MS/PhD)
- Minimum 3 years working within industry.
- Strong technical writing capabilities a plus.
- Experience within cell/gene therapies, biologics, and/or cGMP regulated environment preferred
- Knowledge of process improvement and lean methodologies preferred.
- Ability to interpret and present complex scientific data in a clear and concise manner.
- Proficient in Microsoft office suite and document management systems. Strong organizational and project management skills.