Senior Facilities Compliance Specialist
Pharmacyclics is an AbbVie company focused on developing and commercializing innovative small-molecule therapies for the treatment of certain cancers and immune-mediated diseases. Our hope is that we can change or improve the standard of care for the disease areas we treat or study to continually advance cancer care for patients. Pharmacyclics and its partner, Janssen Biotech, developed and commercialize IMBRUVICA® (ibrutinib), a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor that plays an important role in the survival and spread of malignant B cells. IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably. To date, more than 65,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials. The IMBRUVICA clinical development program is one of the most robust for a single molecule in the industry with nearly 30 company sponsored trials underway, 14 of which are Phase 3. In addition, there are more than 100 investigator-sponsored ibrutinib trials taking place around the world. Pharmacyclics is located in Sunnyvale, California, in Silicon Valley. Pharmacyclics is adding to its Facilities team a Senior Facilities Compliance Specialist. The ideal candidate will implement best practices to streamline QA compliance operations within the facility department. This individual Performs documentation reviews thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls. Supports GMP compliance. The candidate will also assist with the implementation of a CMMS (Computerized Maintenance Management System), EMS (Environmental Monitoring System) application to support assets, and work orders, and monitor critical equipment for the site. The position is responsible for providing a wide range of critical support for Facilities Services. The focus of the position will be QA coordination, planning, scheduling and communication of non GxP and GxP work. Review and update company guidelines, procedures. RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and Procedures
QA review for Deviations, Change request, NCR, and CAPA, and investigations associated with cGMP compliance. Supports change controls related to Quality topics.
Writes new documents and revises existing documents, independently.
Develops and provides training on department-specific procedures and systems.
Participates in internal or supplier audits as needed.
Maintenance of the Equipment Qualification and Equipment Maintenance / Calibration Program.
Train employees on Quality System Procedures.
Review Calibration, Maintenance, and Unscheduled Work Orders for the Facilities Group and outside vendors.
Providing a clear understanding of the Core Technology quality management system requirements (provided by standards, business partners, and regulations)
Writing defensible rationales that follow good technical writing practices (background, supporting evidence, broader justiﬁcation and a decisive conclusion)
Participating in selection, qualification, and management of suppliers and service providers
Proven ability to manage multiple tasks, prepare metrics and meet deadlines.
Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
Experience with supplier quality systems and performing internal audits
Solid understanding of GMP utility systems and manufacturing process equipment.
Previous experience with CMMS (Computerized Maintenance Management System), EMS (Environmental Monitoring System) and BMS (Building Automation Systems) is a plus.
Experience working within QSI Released Documents, Engineering Change Request, Corrective action and NCMR databases
Bachelor Degree or equivalent work experience
3+ years of experience as a QA Specialist within cGMP regulated industry.
Must have Pharmaceutical industry experience.
Computer proficiency on CAD, Word, Excel, Power Point, Outlook, and Microsoft Project preferred.
Must have experience writing AND reviewing SOPs
Strong written and verbal English communication skills.
Strong knowledge of Microsoft office (Excel/Word)