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Job Description:

PRIMARY FUNCTION

Ensure daily operation of the Analytical Laboratory and provide daily support and supervision of its staff.

ESSENTIAL FUNCTIONS

Support/direct activities of the laboratory personnel.
Write and review standard operating procedures (SOPs).
Review and create forms and worksheets to be used within the Analytical Laboratory.
Develop, update and implement laboratory practices in compliance with cGMPs.
Support analytical project related functions including method development or transfer, instrument and supply acquisition and maintenance at all company analytical laboratories.
Maintain Retain Room.
Review analytical data and release batch and finished product.
Review and approve method transfer validations.
Insure the laboratory is in cGMP compliance as well as follows all 6S and Lean Initiatives.

DIMENSIONS

Impact on the organization on a day-to-day basis is primarily involved with insuring that the analytical laboratory has supplies, instrumentation as well as adequately trained staff in order to perform functions.  In addition, to insure that releases, samples and tests are performed in a timely efficient manner in order to maintain production speed and accuracy.  Additionally, and broader in scope, the laboratory functions are driven by regulatory agency legal obligations, requirements and guidelines which support our development as a manufacturer of regulated products.

SPECIALIZED KNOWLEDGE

Requires a bachelor’s degree with a strong emphasis in a natural science.  Master’s degree is preferred.
Prior experience (5 years) managing in Quality Assurance or Quality Control Analytical Laboratory environment.
Requires the ability to read, analyze, and interpret business information, journals, technical procedures, or governmental regulations.
Must have excellent communication skills (written and verbal) to write reports and findings and present to all levels of management in a clear and concise manner.
Strong project management skills.
Strong mathematical concepts such as probability and statistical inference as well as the ability to apply such concepts such as fractions, percentages, ratios, and proportions to practical situations.
PC proficiency to include Microsoft Office (Word, Excel, Access, PowerPoint) along with Microsoft 
Outlook, statistical analysis software, contact management software, and the Internet.

ADDITIONAL ATTRIBUTES

The ability to do work autonomously, however mostly working as part of a team; confident in developing relationships at various levels.
Organized, responsive, proactive team player, able to manage a high volume workload while still staying focused on meeting project and customer objectives.
Professional in all verbal and written communication as well as in face-to-face interaction with customers, employees, and all levels of managers.
Ability to “think on feet”; work under pressure and navigate through quality assurance/quality control issues.
Maintain and expand knowledge of quality assurance/quality control information continuously learning and applying best practices to the organization.

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