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Manufacturing Specialist
2 months ago
Position Overview
Encourages a culture of ongoing enhancement and operational excellence. Takes on leadership responsibilities during shifts when the Supervisor is unavailable. Conducts and coordinates production activities, environmental assessments, and facility sanitation in a cGMP setting. Acts as a certified trainer for manufacturing procedures.
Key Responsibilities
- Recognizes and advocates for initiatives aimed at process enhancement.
- Assumes leadership duties in the absence of the Supervisor, independently guiding the efforts of fellow Manufacturing Technicians to fulfill production timelines.
- Designs studies on manufacturing processes and provides detailed reports on outcomes.
- Engages in cross-departmental project teams.
- Leads and participates in both routine and intricate process improvement projects.
- Demonstrates expertise in quality systems, including root cause analysis, standard operating procedures (SOPs), and corrective/preventive actions.
- Ensures all documentation is accurate and complete.
- Serves as a qualified trainer for the execution of manufacturing processes.
- Maintains proficiency in job responsibilities and performs as necessary.
- Implements procedural steps in accordance with cGMP regulations.
- Oversees environmental control within the facility.
- Completes daily tasks with minimal oversight.
- Collaborates with Quality Assurance to address manufacturing challenges.
Qualifications and Skills
- High school diploma or equivalent is required; a diploma in pharmaceutical manufacturing or a Bachelor's degree in Science/Engineering is considered advantageous.
- A minimum of 4 years of relevant experience is required; prior experience in a regulated setting is essential.
- Familiarity with cGMP and CFR regulations.
- Demonstrates ownership, accountability, attention to detail, adaptability, and strong communication skills.
- Ability to thrive in a dynamic environment and fulfill shift work requirements.
- Pre-employment medical assessment is necessary.
- Become part of a team that provides diverse career paths, competitive compensation, flexible work options, and a comprehensive benefits package.
- Submitted information will be utilized for purposes related to potential employment. Privacy will be maintained.