Operations specialist • tucson az
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The average salary range is between $ 40,000 and $ 106,943 year , with the average salary hovering around $ 43,680 year .
The average salary range is between $ 37,530 and $ 87,749 year , with the average salary hovering around $ 49,889 year .
Job Overview
Requirement/Must Have:
Bachelor's or Master's degree in a Life Sciences (Biology, Chemistry, Biochemistry, Physiology, etc.) discipline.
Excellent stakeholder management, communication, and project coordination skills.
Strong teamwork ethic and exceptional interpersonal skills, with the ability to effectively collaborate across multiple functions, anticipate team needs, and navigate a matrix organization.
Minimum of 1+ years of directly relevant work experience, preferably within the pharmaceutical, biotechnology, or medical devices industry.
Experience operating in a GMP/regulated environment.
Basic knowledge of Lean principles. Familiarity with Six Sigma methodologies is a plus.
Proven ability to strictly follow standard operating procedures (SOPs), operational procedures (OPs), and quality protocols, ensuring compliance and data integrity.
Candidates must have indirect or academic experience in troubleshooting, technical projects, or lab work (e.g., from college courses, a masters program, or tutoring). Direct industry experience is not required.
Candidates must work well with different teams and be capable of managing their own daily tasks independently after initial onboarding and training.
Candidates must have great interpersonal skills, know how to self-manage their workload, and be comfortable escalating issues when needed.
Well suited candidates should display a growth mindset, a strong willingness to learn, and the confidence to ask questions.
Responsibilities:
Execute product design transfer tasks from late-stage development through commercial launch.
Coordinate process transfers from R&D to manufacturing sites (local or external) and track project milestones.
Collaborate cross-functionally with Operations, Development, Regulatory, and Project teams to align on manufacturability, quality, and cost objectives.
Document and integrate end-to-end manufacturing requirements and best practices, including scalability considerations, into transfer projects.
Utilize project management methodologies to execute transfer activities, troubleshoot issues, and support the evaluation of new tools and technologies.
Support process validation readiness by gathering necessary documentation and collaborating with Validation Engineers.
Actively participate in training and mentorship to develop technical excellence within the design transfer team.
Ensure all processes are conducted safely and adhere strictly to current Good Manufacturing Practices (cGMP), local, international, and Client (MQMS) standards.
Assist in audit readiness by collecting and organizing documentation, and supporting non-compliance events.
Keep updated with relevant regulations to maintain company compliance.
Learn and apply basic Lean principles and problem-solving methodologies to identify and eliminate process inefficiencies.
Use statistical tools and software to analyze process data, minimize risk, and generate actionable plans for improvements.
Develop and maintain standardized procedures and documentation for processes.
Skills:
Foundational knowledge in applying scientific methods and principles to process transfer tasks.
Basic understanding of the end-to-end production process for assays and reagents.
Advanced technical writing skills to produce reports and documents.
Strong organizational, critical thinking, and problem-solving abilities, with the capacity to manage multiple low-complexity assignments and meet project deadlines.
