Process & Master Data Governance Manager I

Job Overview:

Pay Range: $70.20hr - $75.20hr

Requirement/Must Have:

• 1-3 years of experience in use and administration of a LabWare LIMS including LIMS Basic.
• Strong working knowledge of laboratory processes including cGMP's in a pharmaceutical environment.
• Experience in system validation, and master data management.
• Familiar with 21CFR part 11 data integrity best practices in pharmaceutical environment.
• Strong verbal and written communication skills and the ability to lead and participate in teams.
• Experience or familiarity of the Laboratory Environment.
• Working knowledge of aseptic processes, biology, chemistry, life sciences with strong supervisory skills.
• Knowledge of cGMPs and regulatory requirements with Strong analytical & balanced decision-making skills.

Responsibilities:

• Ensure site on-time implementation of data remediation activities through support of master data configuration and data migration and SOP revisions.
• Responsible for the master data management process including the updating of specifications, and analysis and supporting the approval and verification process.
• Ensure that the LIMS complies with all relevant regulatory standards.
• Support the business in the creation and updating of training materials as changes to system occur.
• Support the maintenance and improvement of the LIMS system.
• Update master data for new and existing products and analysis.
• Maintain system documentation and provide ad hoc support to other departments.
• Support the creation of updating master data (Product, Item code and Sampling plan) in support of data remediations and SPC projects.

Nice to Have:

• Experience with SQL and database structures.

Skills:

• LabWare LIMS.
• LIMS Basic.
• Master Data Management.
• SQL.
• Database structures.
• cGMP.
• 21CFR part 11.
• Data Integrity.
• System Validation.
• Aseptic processes.

Qualification And Education:

• Degree in Biology, Chemistry, Life Sciences or related field preferred.