Execution of qualification activities (IQ/OQ/PQ) for manufacturing equipment, processes, and materials within Enterprise Quality – Change Management & Systems.
Responsibilities
Hands‑on execution role supporting equipment and process qualification activities within a manufacturing environment.
Draft, execute, and close out Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for manufacturing equipment and systems.
Generate qualification reports, document results, and ensure full traceability of records in accordance with internal procedures and applicable regulatory requirements.
Coordinate closely on the factory floor with Manufacturing, Engineering, Quality, and Project teams to complete qualification testing around production windows.
Support documentation remediation, record management, and change‑control linkage for qualified equipment.
The Sr. Associate Plant Quality Assurance (PQA) on-the-floor position works directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction. It facilitates real-time decision making to ensure adherence to GMP quality requirements.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. 82,081.95USD - 111,052.05 USD
Responsibilities
Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems.
Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations.
Ensure that production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
Senior Associate Quality Assurance – PQA – 1st Shift supporting GMP manufacturing and quality oversight at Amgen’s plant
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Salary Range 82,081.95USD -111,052.05 USD
Responsibilities
Facilitate real‑time decision making to ensure adherence to GMP quality requirements
Provide coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance
Support ANC facility commissioning and qualification and manufacturing Analytical Equipment Qualification and Validation activities
Perform quality review and approval of documents according to project timelines
Provide on‑going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to cGMP, GDP and other regulations
Senior Associate Quality Assurance supporting on‑site manufacturing and quality oversight in a cGMP pharmaceutical plant.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Salary Range 82,081.95USD -111,052.05 USD
Responsibilities
Facilitate real‑time decision making to ensure adherence to GMP quality requirements
Provide on‑going quality oversight for bulk drug substance manufacturing and new product introduction
Support commissioning, qualification and validation activities
Ensure compliance with cGMP, GDP and other regulations
Drive closure of deviations, investigations, CAPA and change control records
Quality Assurance Associate provides administrative and documentation support to the QA team at the LGC Alexandria site.
Compensation
Typical starting pay for this position ranges from $20.00–$25.00 per hour, based on relevant experience, education, skills, and internal equity. The fully established pay range for the position extends up to $30.00 per hour.
Responsibilities
Assist with maintaining accurate and complete electronic and hard-copy quality files
Support the routing of documents for review, approval, revision, and archival
Assist with formatting quality documents using approved templates
Support periodic reviews of files to identify missing, incomplete, or outdated records
Escalate documentation discrepancies to the appropriate Quality Assurance team member
Requirements
High school diploma or equivalent
Nice to have: previous experience in a regulated manufacturing
The role supports QA function's commitment to operating in accordance with cGMP and maintaining a quality system that ensures compliance with regulatory requirements within a highly regulated pharmaceutical manufacturing environment.
Responsibilities
Provide leadership and oversight for Quality Systems activities, ensuring effective implementation and maintenance of the Quality Management System.
Establish effective oversight of Quality System performance through appropriate metrics, trending and review of quality data.
Maintain current knowledge of relevant manufacturing standards, product regulations and global regulatory requirements.
Provide leadership and quality oversight for the Product Complaint and APQR Quality Systems.
Ensure Quality Management Systems are maintained in alignment with data integrity principles.
Requirements
Bachelor’s degree in science or related discipline
Nice to have: advanced scientific or business degree