Manufacturing Operations Specialist
hace 2 semanas
Company Overview:
Quality Consulting Group is a leading provider of pharmaceutical, biotech, medical devices, and manufacturing industry expertise.
Estimated Salary: $80,000-$110,000 per year, depending on experience and qualifications.
Job Description:
We are seeking a highly skilled Manufacturing Operations Specialist to join our team. As a key member of our operations team, you will be responsible for supporting the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
You will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. This role requires strong technical writing and development of reports, as well as project management skills to identify/tracking actions and achieving due dates.
Responsibilities:
- Support the execution of manufacturing/quality systems
- Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations
- Initiate, revise, and approve manufacturing procedures
- Assess process performance by observation of floor operations and review of performance data
- Evaluate, plan, and implement solutions for process improvement opportunities
- Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process
- Collect process-monitoring data and support the assessment of deviations
- Provide support of timely execution of the process monitoring quarterly reports
- Ensure that all Non-conformances are triaged within the established goal
- Responsible for managing NC/CAPA closure within established goal
- Review equipment/system Root Cause Analysis investigations and support trend evaluations
- Assist with generation of process validation protocols and reports
- Assist with the execution of the process validation
- Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications
- Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects
- Assist manufacturing change owner on CCRB packages impacting the process
Required Skills and Qualifications:
- Bachelor's degree in related area
- 5 years of Manufacturing Operations experience
- Experience in handling deviations/non-conformances investigations
- Skills for technical writing and development of reports
- Knowledge and experience with root cause analysis tools (e.g., causal factors analysis, 5 Why's)
- Project management skills on identifying/tracking actions and achieving due dates
- Detailed technical understanding of bioprocessing unit operations
- Skilled in performance of GMP production operations
- Regulatory knowledge and interactions
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
- Organizational, technical writing and presentation skills
- Basic knowledge of control charting
Benefits:
Quality Consulting Group, LLC offers a comprehensive benefits package, including health insurance, retirement savings, and paid time off.
Location:
This position is located in Puerto Rico & USA, with flexible working hours, including weekends.
We are an equal opportunity employer, committed to diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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