Senior Manufacturing Specialist I
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
- Ensure operational efficiency and compliance by managing technical documentation addressing non-conformances and implementing corrective actions.
- Streamline processes and drive continuous improvement across manufacturing operations.
- Effective change management thereby fostering process enhancements and ensuring compliance with regulatory standards.
Operations and Technical
- Conduct technical writing and collaborate with Operations and cross-functional team to investigat non-conformance issues.
- Develop and implement corrective and preventive measures together with the Operations team and cross-functional team.
- Manage change processes to enhance and conduct training modules for Operations and new employee onboarding.
- Analyze key performance indicators and execute strategies to optimize workflows.
- Author and revise GMP-related documents.
- Collaborate on the creation revision and enhancement of electronic batch records.
- Lead or participate in projects aimed at enhancing operations or new product introduction.
- Utilize quality management systems and operations-related software such as Trackwise LIMSSAP POMSnet Delta-V or others.
- Prepare and support regulatory inspections and internal audit.
- Engage in projects aimed at continuous operational improvement.
- Engage in regular GEMBA walkdowns.
- Organize regular meetings with cross-functional teams to discuss and update daily operational matters.
Safety
- Ensures a safe work environment by adhering to regulatory and global/local Environmental Health and Safety (EHS) policies.
Quality
- Ensure investigations are conducted and completed promptly and to a high standard.
- Ensure that process improvements are relevant and beneficial to the manufacturing operations.
- Verify the accuracy of impact assessments and ensure corrective and preventive actions are relevant.
- Serve as point of contact for change management documentation and investigations during audits and inspections.
Schedule
- Strive to complete investigations in a timely manner to minimize any potential impact on batch release timelines or shipment schedules.
- Ensure that process improvement changes are executed on schedule as planned for the production run.
Qualifications :
- Master or Degree with at least 5 years relevant experience in Biologics Production facility or equivalent.
- Good working knowledge of cGMP and regulatory requirements related to Manufacturing is preferred
- Strong working knowledge of GMP systems such as Trackwise SAP LIMS MES systems are preferred.
- Experience with cGMP documentation and record maintenance.
- Experience with Regulatory inspections is required.
- Strong ability to lead and drive cross-functional teams.
- Possesses a positive work attitude and a strong determination to complete tasks efficiently.
- Agility capable of performing under pressure and able to address various priorities.
- Good presentation and strong technical writing skills.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
