Career Opportunities > Quality Systems Specialist

Department: Supply Chain
Location: New York, NY --or-- Stamford, CT
Posted: 10/14/2009
Requisition Number: QA-20091013-SpecQualSys

1 opening
Full-time (exempt)

• Metrics Tracking.
• GMP Auditing / Regulatory / Operational Audit Scheduling – Reporting.
• Training Coordination.
• Validation Management Coordinator – write protocols, review EM protocols, Maintain Master Validation Plan, Provide direction for Cleaning and Sanitization Validation.
• OTC Batch Review.
• Manage Annual Drug Product Reviews.
• QA Change Control Reviewer of Manufacturing processes (second signature). Process Engineer must be primary signatory.
• OOS (Out of Specification) Investigation and review / sign off.
• Procedure writing / Document Control.

• Education: Minimum Requirements: Bachelors Degree in a scientific or engineering field or equivalent experience of at least 4 years.
• Experience: 4-6 years of related experience.
• Time Pressures: Information must be in place in sufficient time to allow ordering and manufacturing to meet the STT.
• Leadership: Must take responsibility for own projects, and be self-motivated.
• Presentational Skills: This position is an important representative of EA Quality and has to be able to handle communications persuasively with vendors.
• Technical: The applicant should be able to discuss and interpret technical data, Packaging Specifications, Formulary Specifications Micro Specifications and be familiar with BOM structures.
• Certifications / Training: Validation Course, cGMP Course and Micro Course / background training.
• Computer / Technical Skills: must be experienced in Microsoft Office (Excel & PowerPoint).
• Strong interpersonal verbal and written communication and computer skills are necessary.
• Technical background necessary, good negotiating skills helpful.
• Strong analytical skills a must.
• Must be customer oriented.
• Some travel may be required.

• Education: Minimum Requirements: Bachelors Degree in a scientific or engineering field or equivalent experience of at least 4 years.

• Please forward a resume in either Word or PDF format to Stamford.Positions@elizabetharden.com. You must indicate the job title in the subject line of your email.