US-MA-Cambridge: Lead QA Specialist

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 19-Dec-2008

Lead QA Specialist

Responsibilities of the position include: -Ensuring appropriate quality systems are in place and utilized in the release of drug substance, drug product, and clinical trial materials. -Conducting/supporting internal and external contractor audits, review of critical cGMP documents, problem solving, participation on project teams, and other associated quality tasks deemed necessary to support the business. -Auditing responsibilities include providing an assessment of compliance status of contractor facilities via the use of FDA's Quality System approach to audits as well as assessing the compliance of internal quality systems and documentation.

Qualifications: - Education Requirements: - Bachelor's Degree -The successful candidate will have an undergraduate education in basic or applied science (chemistry, biological sciences, pharmacology, pharmaceutical science). - A practical working knowledge of computers, computer software applications and data management is necessary as well as training/experience in areas of pharmaceutical industry-related expertise (GLP and cGMP practices), documentation review, validation, equipment qualification, internal and external auditing, and project management. - A current Certified Quality Auditor (CQA) status would be a plus.

Required experience and/or qualifications: - Experience with auditing, ability to work/contribute in a team based environment, and problem solving skills are strongly desired. - Knowledge of the auditing techniques to include use of good interpersonal skills when performing quality system assessments of contract vendors facilities, records, controls and practices, routine monitoring of reports, batch records and stability data as per GLP and cGMP practices. - Audits will also include conducting reviews of internal quality systems, stability data, and study and validation reports. - The candidate will have experience in the creation of standard operating procedures (SOP's). - Three to five years of experience minimum working in a pharmaceutical Quality Assurance environment or related environment is important. - Good verbal and written communication skills are vital to this position. - Experience with computerized record keeping and 21 CFR Part 11 a plus.

For more information, please write to us.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com