Operations & Technical Publications Specialist Sparks Group
Springfield, VA1 day ago
- $24–$38 Per Hour
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Skills
- Automationunmatched
- Budgetingunmatched
- Continuous Improvementunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Data Analysisunmatched
- Data Qualityunmatched
- Document Managementunmatched
- Documentationunmatched
- FDA (Food and Drug Administration)unmatched
- Identify Issuesunmatched
- Lean Manufacturingunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Systemsunmatched
- Microsoft Officeunmatched
- Operational Improvementunmatched
- Organizational Skillsunmatched
- Performance Analysisunmatched
- Presentation/Verbal Skillsunmatched
- Process Developmentunmatched
- Process Engineeringunmatched
- Process Improvementunmatched
- Process Manufacturingunmatched
- Process Validationunmatched
- Productivity Managementunmatched
- Project/Program Managementunmatched
- Root Cause Analysisunmatched
- Standard Operating Procedures (SOP)unmatched
- Strategic Analysisunmatched
- Support Documentationunmatched
- Technical Supportunmatched
- Technical Writingunmatched
- Time Managementunmatched
- Training Programunmatched
- Training/Teachingunmatched
- Writing Skillsunmatched
Description
The Fountain Group is currently seeking a Technical Writerfor a prominent client of ours. This position is located in Rockville, MD.Details for the position are as follows:
Job Description:
Position Summary:
Qualifications:
Key Responsibilities and Duties:
Process Improvement & Optimization
If you are interested in hearing more about the position, please respond to this posting with your resume attached.
Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy
Job Description:
- Location: Rockville, MD (100% Onsite)
- Pay: $32/hr W2
- 6-months contract, high possibility for extension based on performance and budget.
Position Summary:
- The Manufacturing Specialist is a key technical contributor responsible for process optimizations, manufacturing troubleshooting, continuous improvement initiatives to ensure Manufacturing consistently produces quality product.
- 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.
Qualifications:
- Bachelor's degree in relevant Science or Engineering discipline preferred.
- 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.
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 data driven 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, non-conformances, 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.
- 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 ensure adherence to cGMP, process guidelines, and quality requirements.
- Work cross-functionally to ensure employees remain qualified and up to date on process and compliance expectations.
If you are interested in hearing more about the position, please respond to this posting with your resume attached.
Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy
Numbers & Facts
| Location | Rockville, MD |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
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