Specialist QA
About this role
Under minimal supervision, the Specialist QA supports the site Quality Assurance program by ensuring compliance with cGMP requirements, regulatory standards, and internal quality systems. The role provides oversight across manufacturing, environmental monitoring, critical utilities, validation, and quality systems, while driving continuous improvement and maintaining a strong contamination control posture.
FUNCTIONS
- 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.
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.
EDUCATION REQUIREMENTS
- Doctorate OR
- Master’s + 2 years directly related experience OR
- Bachelor’s + 4 years directly related experience OR
- Associate’s + 8 years directly related experience OR
- High School/GED + 10 years directly related experience
Preferred:
- Bachelor’s or higher in Microbiology, Biology, Life Sciences, Engineering, Chemistry, Physics, or Computer Science.
- 10+ years in biopharmaceutical industry with 5+ years in Quality.
PREFERRED QUALIFICATIONS
- Extensive experience in Quality & Compliance, regulatory audits, validation, characterization, and automation validation.
- Strong background in reviewing/approving deviations, EM/CU trend reports, and contamination control documentation.
- Ability to identify quality, compliance, supply, and safety risks and escalate appropriately.
- Administrative Shift
- 1 Year contract
Company at a glance
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results.
Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields.
We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions.
BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
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