Quality Assurance Manager - Biotech Resume Search
Quality Assurance Manager - Biotech Resume Search
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Quality Assurance Manager Resume


Desired Industry: Biotech SpiderID: 50346
Desired Job Location: Brookfield, Connecticut Date Posted: 4/25/2011
Type of Position: Full-Time Permanent Availability Date: now
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Bachelors Willing to Relocate: Yes


Objective:
I am looking for a Quality Management position where I am respected for my work and where I can use my skills to make a contribution to the success of the company. I have six years experience at a medical device / pharmaceutical company in a management role and fifteen years at a consumer product company in various roles.


Experience:
MannKind Corporation, Danbury, CT 2005 - 2011
Quality Assurance Manager (2008 2011)
Developed and implemented new improved quality processes and electronic system workflows (TrackWise) for management of Deviations, CAPAs, Change Control and Product Complaints.
Ensured periodic Management Reviews of the Quality System were conducted. Compiled data, prepared presentation and documented the review.
Prepared and issued Quality Trend Analysis Reports. Compiled the necessary data, analyzed the data and recommended corrective and preventive actions.
Provided direction and leadership to direct reports. Ensured adequate training of staff. Conducted performance evaluations against established objectives.
Conducted Quality System Training as required.
Managed TrackWise System Administration and ensured efficiency of overall system operations.
Supervised the administration of an electronic training management system.

Senior Quality System Specialist (2006 2008)
Managed the process for certification to ISO 13485 and ISO 9001 at the Danbury facility. Ensured that ISO certification was achieved and maintained.
Developed and maintained a corporate Quality Manual, compliant to ISO 13485, ISO 9001, QSR 820 and cGMPs (21CFR parts 210 and 211).
Initiated Management Review and Quality Trend processes.

Quality System Specialist (2005 2006)
Managed CE Mark Registration Process for a class 1 device.
Developed and managed Device Design Control System. Generated required documents (design input documents, Device history file) to met regulatory and ISO requirements.
Initiated a Risk Management process.

Reckitt Benckiser, Parsippany, NJ 1990 - 2005
Quality Engineer (2000 2005)
Led the effort to achieve ISO 9001 certification for the design functions at Regional North American facilities.
Performed quality assessments for potential new suppliers and current suppliers.
Managed the internal audit program for compliance to the ISO 9001 standard.
Participated in New Product Development Projects as quality liaison. Ensured no quality issues for new launches by performing process and design FMEAs and Technical Transfer reviews.
Led consumer complaint priority meetings as required to ensure that the root cause of the issue was identified and Corrective Action was implemented.

Quality Data Analyst (1997 2000)
Developed a consistent training program for the Technical Information System (TIS) which was used by all analysts.
Updated the Technical Information System to support Global Data Standards.
Performed data reconciliation audits to ensure that R&D, Manufacturing and Supply Management Systems were in sync.

I. S. Coordinator (1990 1997)
Assisted in the initial setup and implementation of the Technical Information System. Organized user training, ensured appropriate system security and installed the system software on users' desktops.
Prepared latest view budget reports for all I. S. Departments and coordinated these reports with Finance.
Assisted with implementation of an MRPII system by performing system administration tasks, preparation of training materials and budget tracking.


Education:
BS in Business Administration with Honors, Ramapo College of NJ, Mahwah, NJ


Skills:
Extensive knowledge of the ISO 13485 and 9001 standards.
Expertise in ensuring ongoing compliance to ISO standards and applicable regulatory requirements.
Experienced in development and maintenance of quality systems compliant with federal regulations for pharmaceuticals and medical devices.
Excellent project management and leadership skills with proven results in meeting commitments to timelines while focusing on quality results.
Strong technical skills and experience with computer system validation.


Reference:
Available upon request.


Candidate Contact Information:
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