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| Reference: |
2820 |
| Date Posted: |
4/21/2008 |
| Organization: |
Sterling-Hoffman Life Sciences |
| Employment Type: |
Full Time |
| Location: |
Petersburg, VA |
Description:
Our client is the API production division of a well-respected global pharmaceutical company. The company's growth has outpaced the industry for a number of years and they boast both an experienced management team and a commitment to maintaining a world-class corporate culture. This is a great situation for a candidate that is pursuing a challenging opportunity with the potential for career advancement.
Job Responsibilities:
1) Lead the development and implementation of all policies, processes and procedures
2) Ensure regulatory compliance and organizational effectiveness in the management of the QC laboratory
3) Develop and implement procedures along with optimal infrastructure for the QC laboratory
4) Ensure compliance with all regulatory agencies (e.g. FDA, DEA and EMEA)
5) Provide leadership and direction in the areas of organizational design, performance management, succession planning, leadership development and training for the QC laboratory
6) Ensure timely and accurate testing and recording of all API and related chemicals
7) Provide leadership for analysts of the quality improvement process, to optimize productivity in and quality of work from the QC laboratory
8) Ensure analyst safety in all laboratory activities
9) Provide direction in implementing systems and processes
10) Create infrastructure as well as provide vision and direction for QC laboratory functions
11) Ensure optimal efficiency in testing, reporting and final approval processes
12) Liaise with Production, Supply Chain and Customer Service Departments for QC laboratory
Job Requirements:
1) Ph. D. in Chemistry with minimum 4 years of experience or BS with a minimum 7 years of experience
2) 10+ years of experience in GMP quality in the pharmaceutical industry
3) Experience in managing a quality group of 25+ people
4) Minimum 5 years of management experience in an analytical and regulatory environment
5) Working experience in a pharmaceutical company (except medical devices)
6) Experience in developing and managing budget plans as well as forecasts
7) Expertise in using business systems such as SAP, LIMS, EMPOWER, TRAKWISE, etc.
8) Knowledge of creating a standardized format or input data and using programmed computer applications to generate and/or process data and/or create documents
9) In-depth knowledge of analytical analyses concepts and experiments, including wet chemistry techniques and instrumental analyses
10) Expertise in applying and evaluating relevant algebraic concepts, using and deriving lab equations and performing statistical analysis at a sophisticated level
11) Ability to lead, motivate and communicate effectively with the staff and chemists
12) Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
13) Ability to deal with non-verbal symbols (formulas, scientific equations, graphs, etc.)
14) Ability to read, interpret and create required technical documents
15) Ability to accurately report and communicate progress of group tasks in a graphical, tabular, narrative and/or verbal format
16) Ability to frankly and tactfully convey performance status to supervisors and staff chemists
17) Ability to direct Out-of-Specification (OOS) investigations and review for accuracy
18) Ability to communicate effectively with the company staff, management as well as other corporate and worldwide groups
Applicants are encouraged to apply directly by going to:http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02820.html
Salary: $160k- $180k
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| Healthcare Field: |
Allied Health |
| Category: |
Medical Laboratory Technician |
| SubCategory: |
None |
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Job Posted By:
Similee Harvey
Sterling-Hoffman Life Sciences
800 West El Camino Real ,Suite 180
Mountain View
United States
94040
View more jobs posted by Similee Harvey |