- Analyze current processes to identify bottlenecks and areas for improvement.
- Develop and propose solutions to streamline processes, improve product quality, and ensure regulatory compliance.
- Develop timelines and project plans for process improvement initiatives, outlining key milestones, deadlines, and resource requirements.
- Identify opportunities for optimization, cost reduction, and risk mitigation within manufacturing, quality control, regulatory compliance, and supply chain management.
- Ensure all processes meet regulatory requirements and industry standards for safety, efficacy, and quality.
- Coordinate with cross-functional teams to align efforts and resources towards common process improvement goals, involving facilitating meeting, fostering collaboration, and resolving conflicts to keep projects on track.
- Maintain detailed documentation of process improvements, including standard operation procedures, work instructions, and validation protocols. Prepare reports and presentations to communicate progress to stakeholders.
- Collaborate with various departments and stakeholders, including R&D, manufacturing, quality assurance, regulatory Affairs, supply chain management, and external vendors, to drive process improvement initiatives.
- Bachelor of Science degree in Biology, Chemistry, Engineering, or a related field required.
- 5-7 years of experience in process improvement, quality control, or compliance within the pharmaceutical industry.
- 5-7 years of experience utilizing various software, including LabX, UPLC, etc.
- Strong knowledge of pharmaceutical manufacturing processes, regulatory requirements, and quality standards.
- Experience with qualification protocols and validation activities.
- Excellent analytical skills with the ability to identify problems, propose solutions, and drive implementation.
- Thorough understanding of pharmaceutical regulations and quality standards, including GMP, GLP, and GDP.
- Strong project management skills with the ability to establish timelines, manage resources, and deliver results.
- Excellent communication and interpersonal skills with the ability to collaborate effectively with cross-functional teams.
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Process Improvement Specialist - Millburn, United States - Medasource
Description
Apply Now
<<Title: Process Improvement Lead
Length: 8-month contract
Location: Millburn, NJ (5 days onsite)
Project Goal & Overview:
Our client is seeking a highly motivated and experienced Process Improvement Lead, responsible for developing solutions to streamline processes, improve product quality, and ensure regulatory compliance. This individual must be an expert in process improvement, quality control, and compliance. We are looking for this person to be a strategic thinker, great team player, and a true problem solver.
Deliverables/Milestones:
Qualifications:
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.
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