Quality Assurance Associate

3 weeks ago

Malvern, United States Insight Global Full time

Required Skills and Experience:

-Bachelor's Degree required in Science, or equivalent technical subject area

-5-7 years of experience working within the pharmaceutical field within QA activities (quality oversight) in GMP manufacturing

-Strong experience working with change controls


Nice to Have Skills and Experience:

-Clinical product experience

-GMP Manufacturing equipment or automation validation experience

-Manufacturing execution software experience

-Quality investigations experience

-Trackwise

-Commit and SAP software experience


Job Description:

In this role, you will be providing quality oversight for daily activities related to commercial supply chain operations supporting production of commercial and clinical drug substance in the biotherapeutics product portfolio. You will act as a liaison with other internal quality organizations to standardize policies, practices, and procedures to increase quality and compliance and champion increased awareness of quality related concerns.


The QA Associate is responsible for providing Quality Assurance and Quality Oversight services to designated manufacturing sites. This role ensures the manufacturing site maintain a state of inspection readiness through internal audits and by assuring compliance with regulatory requirements. The associate ensures compliance with cGMPs and is responsible for performing regular scheduled oversight within manufacturing, and warehouse areas to ensure inspection readiness at all times.


Key Responsibilities:

Provides Quality review and guidance associated with investigations, change controls, protocols, reports, area releases, project planning and site procedures.

Provide quality input on a variety of compliance related issues and attend meetings as a quality representative.

Act as Quality representative to provide on the floor and on-call quality support in Manufacturing Operation and escalate issues to quality management for consultation.

Partner with QA Document Control, QC, Manufacturing, Execution Systems, Plant Logistics, Validation/Compliance, and Regulatory Affairs to ensure documentation/process changes align with regulatory filings and maintain validated process.

Increase the compliance profile by identifying gaps within processes and procedures.

Provide support on Local and Global Change controls-related items such as providing input on the proposed changes impact assessments and implementation plans.

Revise and acquire approval for departmental documents and coordinate document approvals against timelines.

Support internal and external audits, inspections, FDA pre-inspection readiness, certifications, tracking, and trending activities.

Support the maintenance program by reviewing, approving, and documenting within SAP, Work Orders, PM/Calibration Extensions, and PM/Calibration Change Requests.

Work independently on routine tasks and will have support to resolve some complex technical issues.

Ensure all non-conformances are fully investigated and effective corrective/preventive actions (CAPA) are implemented in a timely manner.

Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies.

Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.

Review production documentation and provide guidance to resolve quality related manufacturing issues and/or documentation discrepancies.

Support quality activities related to Batch Record Review, Intermediates and Finished Product Releases.

Author and revise quality departmental documents.

Supports site inspections and inspection readiness activities. Ensure the site is audit ready. Support data integrity efforts.

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