Process & Master Data Governance Manager I (Onsite)

Aequor; Swiftwater (Monroe County); On-site; USD 75,000 - 120,000; Full time

Job summary

A leading company in pharmaceutical manufacturing seeks a Process & Master Data Governance Manager I in Swiftwater, PA. This role involves LIMS administration, ensuring regulatory compliance, and supporting business operations through effective data management. Candidates should possess strong analytical skills and a background in laboratory processes within a cGMP environment.

Qualifications

• 1+ years of experience in the administration of LabWare LIMS.
• Strong working knowledge of laboratory processes including cGMP’s.
• Experience in system testing and validation.

Responsibilities

• Ensure on-time implementation of new iSHIFT system activities.
• Provide technical support of LIMS to Quality Control and Production.
• Responsible for master data management including updates and approvals.

Skills

Excellent written and verbal communications

Strong analytical skills

Good GMP documentation

Tools

LabWare LIMS

Job description

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Title:- Process & Master Data Governance Manager I

Location: Swiftwater, PA

Job id:- SNFIJP00009946

Basic Requirements:

Must have 1+ years of experience in use and administration of LabWare LIMS specifically creation of product specs, sample plans and item codes.

- Strong working knowledge of laboratory processes including cGMP’s in a pharmaceutical environment

- Experience in system testing, validation, and master data management

- Familiar with 21CFR part 11 data integrity best practices in pharmaceutical environment

- Excellent written and verbal communications skills and the ability to lead and participate in teams

- Experience or familiarity of the Laboratory Environment

Position Responsibilities:

- Ensure site on-time implementation of new iSHIFT system (ERP) activities through support of master data configuration and data migration and SOP revisions.

- Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability and R&D operations

- Provide first level diagnostic of incidents and support business users, IS LIMS Administrator and Support Center in the management and timely resolution of technical

- Responsible for the master data management process including the updating of specifications and supporting the approval process

- Manage Global System update and changes which may include new modules and workflow changes

- Configure and Maintain instrument interfaces to Laboratory equipment

- 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

- Ensure that the LIMS complies with all relevant regulatory standards

Technical competencies and soft skills:

Working knowledge of aseptic processes, biology, chemistry, life sciences

Knowledge of cGMPs and regulatory requirements with Strong analytical & balanced decision-making skills

Good GMP documentation

MINAKSHI SANGWAN

Recruiting Lead - US Recruitment

O 732-339-3518

W http://www.aequor.com/

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Other

• Industries

  Pharmaceutical Manufacturing

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