QC Specialist II, Documentation Job

Employer Name: HSS	SpiderID: 2900091
Location: Danbury, Connecticut	Date Posted: 9/23/2009
Wage:	Category: Biotech
Job Code:
Number Of Openings: 1

Job Description:
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting document audits, training programs, data and documentation reviews and analysis. Writes and revises standard operating procedures, test methods, and specifications.

Section II: Essential duties and key job responsibilities and essential functions.
Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions on new assignments.

• Perform review of study controlled documents (SOPs, TMs, Specifications, Change Controls, Batch records) to internal company documents and external regulations.
• Create and/or revise departmental SOPs.
• Assist in internal audits and ensures that QC SOPs, Test Methods and Specifications are revised periodically as required by QA.
• Assist with training and acting as a department liaison to help facilitate the resolution of quality issues or questions.
• Review compliance to the Change Control System. Work with Change Control Review authors to prepare and facilitate review of major change request. Ensure that CCRs submitted meet CCR requirements and are suitable for review. Ensure that approved and closed CCRs are accurately updated in the document control system in a timely manner. Facilitate company use of required CCR preparation processes and documentation systems. Manage all respects of CCRs reporting as needed.
• Ensure document content, formatting, and organization meets requirements and retains technical accuracy.
• Facilitate company use of required documentation preparation processes and documentation systems. Manage all aspects of document conversion process as needed.
• Implement improvements in current document control systems, provide written procedures, reviews and comments on related documentation procedures, and ensure their proper implementation.
• Communicate with appropriate departments to ensure changes are well documented and easily understood.
• Interact with appropriate departments to establish priorities and deadlines for processing requests.
• Ensure the correct and timely implementation of requests and coordinates the resolution of problems. Develop and communicate both drafting standards and change control process standards.
• Coordinates the compilation of QC documents for Regulatory Submissions
• This position may have indirect supervisory responsibilities but will have project related leadership responsibilities.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.

Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

As a member of the Quality organization at Company the incumbent is also expected to use quantitative reasoning; to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player.

Job Requirements:
• Requires a Bachelor’s degree in a scientific discipline from an accredited college or university or equivalent.
• 4 to 7 years experience with Bachelor’s degree, 0-3 years with Master’s.
• Possess strong organizational, project management, communication and writing skills. Should have analytical laboratory experience, preferably in a cGMP environment, experience with both microbiology and analytical chemistry a plus, and experience writing SOPs, Test Methods, and Technical Reports.
• Proficiency in MS Word, Excel, Access, and PowerPoint. Excellent communication skills, both written and verbal; strong interpersonal skills.

Job Criteria:
Start Date: 10/01/2009
Position Type: Full-Time Temporary
Years of Experience Required: 3
Education Required: Bachelors
Overnight Travel: None
Vacation Time: No Paid Vacation

Contact Information:

Contact Name: Omer Mutaqi	Company Type: Recruiter
Company: HSS	Phone: 203-855-8900
Street: East Av	Fax:
City: Norwalk
State: Connecticut
Zip: 06851

Web Site: http://horizonstaff.com