Clinical Quality Assurance Auditor

CLINICAL QUALITY ASSURANCE AUDITOR




Barr Pharmaceuticals, Inc. a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develops, manufactures and markets more than 100 generic and proprietary pharmaceutical products in core therapeutic categories including female healthcare, oncology, cardiovascular, anti-infective and psychotherapeutic pharmaceuticals. The Company's generic products are marketed under the Barr label and proprietary products are marketed under the Duramed label. Barr is the leading supplier of oral contraceptive products in the United States.



In fiscal 2005, Barr recorded total revenue of $1.05 billion and invested $128 million in product research and development. Barr has operations in New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington, DC - and employs more than 2,000 employees.



We have an outstanding career opportunity for a successful Clinical Quality Assurance Auditor located in our Bala Cynwyd, Pennsylvania offices.

Responsibilities include:

Ensuring that processes, procedures and activities are in compliance with GCPs and other prevailing regulations and guidances.
Conducting and/or overseeing audits of internal procedures, clinical study reports, CROs, clinical investigators, contract labs, SOPs and outside vendors
Providing CQA representation to project teams
Assisting in the creation and maintenance of CQA SOPs and audit tools
Investigating and resolving compliance problems and questions regarding Regulatory Affairs, Clinical Operations, Data Management, Statistics, and Safety
Conducting GCP Training
Assist with hosting regulatory agency inspections

Position Requirements include:

MS/BS degree in Scientific Discipline/ Life Sciences preferred
3-5 years experience in Clinical Quality Assurance
Thorough knowledge of Good Clinical Practices (GCPs), quality systems (SOPs) and audit procedures and reporting
Experience applying principals of 21 CFR Part 11 to clinical systems
Capable of writing effective SOPs, Quality Assurance Reports and training materials
Ability to communicate effectively and non-confrontationally with internal departments
Ability to multi-task; to develop systems and SOPs while reviewing protocols and report
Capable of planning activities to meet CQA objectives
Ability to resolve / document quality problems as appropriate and know when to elevate problems to a higher level




Commitment to Excellence - Many companies talk about it. Barr delivers - every day, to our customers AND to our employees. Barr's commitment to employees is reflected in our total compensation and benefits package that includes competitive salaries and incentive compensation programs, career opportunities offering both personal and professional growth; a 401(k) plan that matches up to an additional 10% of your pay each year; a stock purchase plan that allows you to buy company stock at 15% below market; comprehensive medical and dental plans that provide coverage for you and your family with nominal employee cost; life and disability protection programs and so much more! Together, we raise the BARR!




We are an Equal Opportunity Employer m/f/d/v.