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QC Microbiology Lab Manager

Job Description
Position Summary:
Develop and oversee the Quality Control chemistry program to ensure products are tested in compliance with applicable US Federal and International regulations.
Provide support to Production & Registration Departments on international (e.g., Canada, Europe) QC and other related regulatory standards. Assist Management in responding to FDA and other regulatory agencies on technical issues.
Ensure that QC personnel interact effectively with the Quality Assurance Unit, Manufacturing personnel, and Engineering personnel.
Provide training and development to assure group personnel are adequately skilled to perform assigned functions and that the group operates in an orderly and efficient manner.
Essential Duties & Responsibilities
Develop, validate and approve methods
Plan and direct projects
Evaluate and specify instrument purchases
Design, implement, approve and assign operational procedures
Develop and direct execution of protocols
Review and approve data
Write and review reports
Trainer for advanced techniques, methods and theory
Represent QC Microbiology Lab in audits
Prepare department forecasts
Internal and External customer interface
Overall responsibility for the site environmental monitoring and cleaning surveillance programs
Present and publish papers
Ensure compliance to relevant GMP/GDP And Quality Systems standards
Prepare and present reports of departmental measure of appropriate quality to internal management.
Establish and maintain documented processes to ensure that product disposition and release of compliant product are performed within agreed lead-times.
Education & Special Training
B.S./ B.A. in Microbiology or a related technical field is required, an advanced degree is preferred.
Experience must include microbiological testing of products in accordance with compendial methods (USP , USP , USP preferred)
Experience must include a management position in an FDA GMP (Good Manufacturing Practice) compliant laboratory.
Experience with a Laboratory Information Management System (LIMS) is a plus
Strong analytical and communication skills are essential with the ability to manage personal and team workloads to ensure high standards are maintained.
Awareness/understanding of company products, processes, procedures and personnel.
Qualifications & Experience
10+ Years' relevant experience with B.S./B.A.
6+ Years' relevant experience with M.S.
3+ Years' relevant experience with Ph.D.
Proven experience in quality management and improvement
In depth understanding of quality control procedures and relevant legal standards
Excellent math abilities and working knowledge of data analysis/statistical methods
Experience with Continuous Improvement tools and applications
Excellent organizational and leadership skills
Experience in Quality Risk Management
5 to 10 years' business experience working with Pharmaceutical Quality Control/Quality Assurance
Work From Home: No
Travel Percentage: Up to 25%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.


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