Senior Document Control Specialist
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
General Position Summary:
Executes and maintains compliant, efficient Quality Assurance Document Management systems and procedures.Key Accountabilities/Core Job Responsibilities:
Independently performs day-to-day Document Control activities: Process DCR packages and review for correctness and completeness; monitor and update in-process documents; create, assign and archive QA controlled lab notebooks and logbooks; maintain the electronic document management system; maintains Master Documents in the Document Control Vault; and create reports.
Performs duties in support of established records management procedures, including scanning, filing and managing offsite records storage and retrieval.
Assist in the preparation of document control metrics and reports
Initiates SOP updates and creation of new SOPs.
Provide back room support for regulatory inspections
Provide user assistance and training on document control systems and procedures
Bachelor's Degree or equivalent professional experience
2-5 years of pharmaceutical experience in a GMP environment administering Document Control Systems.
2 years experience using and administering electronic document management tools
- Working knowledge of Quality Systems, GMP-related requirements and ICH guidelines, desirable.
- Working knowledge of electronic documentation systems, data retrieval, and electronic file formats
- Detail oriented with solid problem solving acumen.
- Ability to work effectively in a team environment.
- Ability to analyze and reconcile moderately complex issues.
- Must have demonstrated initiative and accountability in a fast paced environment.
- Must demonstrate leadership skills through example.
- Excellent verbal and written communication and interpersonal skills.
- Proficient with computers and word processing software (i.e. Microsoft Office products).