Specialist QA

Position Summary:

The AIN Specialist QA plays a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network. The Specialist QA will leverage industry, technical, and quality systems knowledge to provide support of product expiry management processes, product complaints processes, disposition manager training, and fulfillment of disposition related data requests across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions.

This candidate will primarily work during regular working hours (9 am 6 PM local time) to enable the business in delivering Amgens mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones globally.

Key Responsibilities

DSI/DS/DP material shelf-life extension

• Executing the GMP process to extend expiration dates for clinical and commercial products produced at Amgen.

• Updating batch product expiration dates in the Amgen SAP inventory management system.

• Evaluating (approve or reject) expiry-SAF forms (expiry stability assessment forms).

Disposition Support of Partner Requests

• Support requests made by Amgen partners for data and information related to their partnered product batches manufactured at Amgen sites.

• Data recovery from systems including, but not limited to, manufacturing execution system electronic batch records, the quality control laboratory information system, the regulatory information management system, and the Amgen enterprise resource management system (SAP).

• Uploading and communication of collected data to Amgen partners.

COA Generation, special requests after disposition

• Generation and provision of Certificate of Analysis (CofA) records for Amgen drug substance, drug product, or final drug product batches.

• Uploading and communication of collected documentation to requestor (i.e. Amgen partners, regulatory compliance to support RTQs, process development).

Disposition Manager Training

• Execution and delivery of quality systems training to new disposition managers across the Amgen network via virtual meetings.

• Training subject matter to include use of quality systems applied to execute the disposition process (i.e. ERP/SAP, MES/EBR, ARRS, LIMS, TW, CDOCS, DQMS, Kneat, etc.)

• Maintenance and revision of training document materials in the controlled documents management system (CDOCs).

Product Complaints

• Execution of the drug substance, drug product, and final drug product complaint full batch record review process.

• Assessing electronic batch record (EBRs) documentation in the manufacturing execution system (MES) to identify any potential issues relevant to the complaint.

• Recording the results of the complaints batch record assessment in the Bioconnect quality system.

Preferred Qualifications

• Experience in project management and related systems

• Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred.

• Excellent verbal and written communication skills

• Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting.

• Experience in manufacturing environments

Core Competencies

• Experience working in a regulated environment with knowledge of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) requirements.

• Experience working with Quality Systems that may include enterprise resource planning (ERP/SAP), regulatory information management (RIM), controlled document management (CDOCS), change control (QMTS), deviation (DQMS), and quality control laboratory information management systems (LIMS).

-Experienced in staff training and development.

• Technical Document Drafting and Workflow Ownership

Basic Qualifications and Experience:

Masters degree with 8-12 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.