Manufacturing Compliance Analyst
1 week ago
Innova Solutions is seeking a Deviation Management Specialist to join our team.
Role Overview:
The Deviation Management Specialist will play a crucial role in providing technical support to our manufacturing operations. This position focuses on the identification, resolution, and minimization of process deviations while also spearheading investigations related to manufacturing processes.
Key Responsibilities:
- Deliver daily technical assistance to manufacturing teams, ensuring effective resolution of process deviations.
- Develop and implement corrective and preventative actions to enhance operational efficiency.
- Collaborate with cross-functional teams to support aseptic manufacturing, testing, planning, and product release.
- Conduct thorough troubleshooting and root cause analysis for laboratory test failures and atypical manufacturing events.
- Utilize critical analytical thinking to analyze complex problems and propose effective solutions.
Qualifications:
- Bachelor's or Master's degree in a relevant engineering or scientific discipline.
- 0-3 years of experience in a cGMP environment within the pharmaceutical or biotech industry.
- Experience in documenting investigations for atypical events in a manufacturing context.
- Familiarity with Lean Six Sigma methodologies and strong analytical problem-solving skills.
- Proven ability to meet deadlines and manage organizational tasks effectively.
- Ability to work independently as well as collaboratively within a team environment.
Preferred Skills:
- Experience in environmental monitoring, formulation and filling processes, and line manufacturing.
- Background in project engineering, maintenance, or facility engineering in bulk/drug substance manufacturing.
Innova Solutions is an Equal Opportunity Employer, committed to fostering a diverse and inclusive workplace. We encourage all qualified candidates to consider this opportunity.
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