Specialist QA Details

Specialist QA

Biopharma Consulting Services - Juncos, PR

Employment Type : Full-Time

Perform one or more of the following duties and responsibilities in support of Amgen’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation. Ability to evaluate compliance issues, Demonstrate the Amgen Values/Leadership Practices.
Support various Transfer/Incoming/Validation activities across various areas such as Incoming/QC/Process Development/Facilities so experience in Qualification/Validation activities is a must
Experience on the following:

• Quality Assurance (QA), Quality Control (QC), or Incoming. Preferably in QA
• Deviations, Data integrity, Validation, Work Orders (WO), Equipment Alarms, Compliance, Investigations, Technical Support, or Regulatory reviewing and approving records.

Highly Desirable:

• Experience with managing records in Trackwise, review and approval of validation records and documentation

• Experience in Change Control and managing Deviations

Job Types: Full-time, Contract

Pay: $0.00 per hour

Schedule:

• 10 hour shift
• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• Incoming: 5 years (Required)
• QC: 5 years (Required)
• Process Development: 5 years (Required)
• Qualification: 5 years (Required)
• Validation: 5 years (Required)
• Quality Assurance: 5 years (Required)
• Deviations: 5 years (Required)
• Trackwise: 5 years (Required)

Language:

• Spanish/ English (Required)

Contract Length:

• More than 1 year

Work Remotely:

• Temporarily due to COVID-19

COVID-19 Precaution(s):

• Remote interview process
• Personal protective equipment provided or required
• Temperature screenings
• Social distancing guidelines in place
• Virtual meetings
• Sanitizing, disinfecting, or cleaning procedures in place