Contamination Control Process Owner responsible for implementing and maintaining contamination control strategies, SOPs, and audit readiness within Amgen North Carolina manufacturing operations.
Compensation
Salary Range 107,545.40USD -145,502.60 USD
Responsibilities
Implement contamination control strategy and procedures
Maintain audit inspection readiness
Coordinate process-level assessments and improvement actions
Support continuous improvement initiatives
Lead or contribute to local process assessments
Requirements
Doctorate degree
Master's degree in Engineering, Biology, Chemistry, Biochemistry, or related field
The Director, Global PV Management is responsible for assessing regional and international pharmacovigilance regulatory requirements and translating them into effective drug safety & pharmacovigilance procedures and operational processes.
Locations (3)
San Francisco, California, United States
San Diego, California, United States
Princeton, New Jersey, United States
Compensation
$194,600—$243,300 USD
Responsibilities
Review and interpret applicable international and regional pharmacovigilance regulatory requirements
Continuously monitor changes to pharmacovigilance requirements in countries where the company operates
Assess pharmacovigilance requirements for new countries and develop operational readiness plans
Conduct and document gap assessments comparing regulatory requirements with existing SOPs
Senior QA Specialist (Consulting) supporting Cencora’s patient and provider support and pharma commercialization services in Canada through Innomar Strategies.
Responsibilities
Maintain importer Drug Establishment Licenses and approval process for foreign sites
Coordinate with clients and foreign sites for document review and updates
Release commercial drug products and clinical trial supply to Canadian market
Review and assess documents from clients/foreign sites
Assist in KPI preparation and reporting
Requirements
Bachelor’s degree in a pharmaceutical or healthcare related field
Nice to have: Regulatory Affairs or QA Certification
Oversee laboratory quality control activities related to sampling, testing, evaluation, and release of bulk cosmetic, personal care, and OTC drug products.
Compensation
$70,000–$80,000 annually, based on experience, skills, and qualifications.
Responsibilities
Lead laboratory testing and quality evaluation of bulk products
Oversee routine laboratory activities and critical quality attribute assessments
Review and approve test results, coordinate investigations and corrective actions
Manage bulk product sample collection, labeling, storage, and control
Ensure compliance with FDA regulations, GMP requirements, and ISO standards
Requirements
Bachelor's degree in Chemistry, Cosmetic Science, Pharmaceutical Science, or a related scientific discipline
Nice to have: Master's degree in a relevant scientific discipline
Nice to have: experience with colour cosmetics, skincare, haircare, or OTC products
Nice to have: previous laboratory supervisory or team leadership experience
Nice to have: experience supporting audits, deviations, CAPA activities
Responsible for ensuring safe, efficient, and compliant packaging operations across contract manufacturing sites, driving equipment qualification, validation, and continuous improvement.
Responsibilities
Conduct qualification and validation activities for new packaging equipment and products
Troubleshoot packing line breakdowns and conduct root cause analysis
Implement corrective actions and monitor performance data
Support project teams and CMs for user requirement specifications and validation protocols
Identify improvement opportunities and drive continuous improvement projects
Senior QC Specialist in the Bioassay Laboratory responsible for establishing laboratory capabilities, supporting analytical method transfers, and ensuring quality of biological medicines.
Technical Engineer (Maintenance, Energy) in Lendava
Compensation
Tehnik tehničnih storitev II: 20.320 - 30.480 EUR
Responsibilities
Izvajanje preventivnega in kurativnega vzdrževanja proizvodne in infrastrukturne opreme
Spremljanje delovanja sistemov ter zagotavljanje njihove visoke razpoložljivosti
Sodelovanje pri diagnostiki napak, odpravi odstopanj in implementaciji CAPA ukrepov
Podpora pri kvalifikacijah in validacijah (IQ/OQ/PQ) ter uvajanju nove opreme
Upravljanje in nadzor tehničnih sistemov (energetika, čisti mediji, HVAC, ipd.)
Requirements
High school diploma or higher in mechanical engineering, electrical engineering, mechatronics, energy engineering, automation, computer science or other technical field
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