GMP Bio pharmaceutical Experience either manufacturing or Quality– must have minimum 2-3 years
Quality Experience of GMP Operations – 2 yearms
Day to Day Responsibilities:
Quality oversight of manufacturing operations
Review and approval of electronic batch records, SOP and other source documents
Quality review and approval on deviation
real time decision making on the floor with manufacturing
The Quality Assurance Specialist will be responsible for PQA On the Floor in support of Manufacturing activites.
This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.
This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff.
Amgen’s Quality Assurance On-the-Floor position Shift 2 (4 days a week Tuesday through Friday 10 hours per day 1pm – 11pm provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regard to compliance and quality systems with the adaptability to support alternate shifts as the business need requires.
Responsibilities include the following:
Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
Ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, Corrective Action/Preventative Actions (CAPA),
Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
Establish and enable LEAN practices.
Oversee and provide guidance during on-the-floor analytical testing.
Ensure that changes that could potentially impact product quality are assessed according to procedures.
Ensure that deviations from established procedures are investigated and documented per procedures.
Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
Alert senior management of quality, compliance, supply and safety risks.
Complete required assigned training to permit execution of required tasks.
Drive operational improvement initiatives, programs and projects.
Master’s degree and 1 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
Bachelor’s degree and 2 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
Associate’s degree and 5 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
High school diploma / GED and 7 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
Previous QA oversight of manufacturing, analytical and engineering activities
Experience in investigations, change controls, and CAPAs processes system knowledge
Direct Validation experience with pharmaceutical or biopharmaceutical processes
Ability to evaluate compliance issues and interact with regulatory inspectors
Experience and training in EDMQ, Trackwise, Maximo, LIMS
Experience in managing multiple, competing priorities in a fast-paced environment
Experience leading and/or managing teams
Direct bulk drug substance and drug product experience
Ability to solve complex problems and make scientific risk-based decisions
Experience representing Amgen while interacting with representatives of regulatory agencies
Experience of trending analysis
Demonstrated proficiency using Excel, Word and Power Point
"This posting is for Contingent Worker, not an FTE"