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Manufacturing Process Specialist
2 months ago
Company Overview: Society of Exploration Geophysicists is a leading organization dedicated to advancing the science of geophysics and providing essential resources for professionals in the field.
Position Title: Process Scientist
Job Location: Not specified
Contract Duration: Long-term opportunity
Compensation: Competitive pay rate
Essential Skills:
- Veeva
- Change control management
- Risk assessment
- SOP revisions
- Impact assessments
- Investigations
- Quality Assurance Reviews (QAR)
Position Summary:
The Process Scientist will play a crucial role in the manufacturing support operations within a cGMP environment. This position involves overseeing the execution of manufacturing processes for various products, ensuring compliance with industry standards and regulations.
Key Responsibilities:
- Manage and contribute to project completion while adhering to established timelines.
- Provide technical support within the assigned group and collaborate with external teams as necessary.
- Act as the primary operations contact for campaign start-up and documentation generation.
- Support audit activities by ensuring effective communication and preparing responses to findings.
- Implement and oversee Corrective and Preventive Actions (CAPA) and change control processes.
- Conduct risk assessments and participate in compliance improvement initiatives.
- Facilitate training sessions and ensure adherence to safety protocols.
- Prepare for regulatory inspections through thorough assessments and compliance checks.
Qualifications:
Required:
- High School Diploma or equivalent with 8 years of relevant experience, or an Associate's degree with 6 years of experience, or a Bachelor's degree with at least 2 years of experience, or a Master's degree with 0-1 year of experience.
- Strong verbal communication skills and the ability to mentor others.
- Proficiency in Microsoft applications and process tracking software.
- Able to work independently and collaboratively in a team setting.
Preferred:
- Master's degree and experience in the pharmaceutical industry.
- Certifications in Continuous Improvement or Project Management.
- Previous experience in a GMP manufacturing environment.
- Familiarity with mammalian cell culture and filtration processes.
Physical and Mental Requirements:
The role requires mobility throughout the manufacturing area, including navigating stairs and conducting detailed document reviews.
Education and Experience:
A Bachelor's degree in chemical engineering, biology, biochemistry, or a related field, with a minimum of 4 years of relevant experience, or a Master's degree with 3 years of experience.
