ManagerTL Quality Control
Share
Job Location:
Rochester, NH - USA
Monthly Salary:
$ 102900 - 171500
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Use Your Power for Purpose
This position will oversee the Quality Control Laboratory in Rochester MI. The Rochester Quality Control Laboratory performs: Assay Viscosity Breakloose & Extrusion Sterility Gas chromatography pH LOD Bacterial Endotoxin Karl Fischer and multiple other analytical technologies used to determine quality attributes for Rochester manufactured Drug Products.
The selected candidate will lead the laboratory to meet defined quality standards and QO objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards company policies practices and processes. Fosters teamwork and colleague development as well as change management within the laboratory and department. Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values norms and behaviors. Provides oversight to individuals and team on personal development performance and quality related issues. Writes and delivers performance reviews and oversees colleague development. Provides oversight of department ensuring proper use of assets budget and personnel.
What you Will Achieve
Review and approve cGMP documentation to assure compliance with regulatory requirements.
Assess deviation impacts and resolve to prevent future occurrences.
Review and approve cGMP Changes in accordance with regulatory requirements.
Review and approve training to assure cGMP requirements are met.
Manage resources (people and assets) to meet work team goals.
Support a continuous improvement culture where individuals can thrive in change.
Thoroughly evaluate lab investigations deviations and associated corrective/preventive actions to ensure they are handled appropriately and documented effectively as they relate to the testing of raw materials in-process samples and final products.
Assures adherence to data integrity initiatives.
As a Subject Matter Expert (SME) represents the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of QO.
Supports and may lead implementation of various elements ofIMEx.
Here Is What You Need
(Minimum Requirements)
Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
Previous experience with leading colleagues and/or projects is required.
The candidate must have excellent verbal and written communication skills with the ability to share vision direction and data with colleagues across all levels and in a wide range of different work groups.
The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.
Bonus Points If You Have
(Preferred Requirements)
The candidate should have experience in multiple of the following areas: cGMP Regulatory deviation investigations drug product lot release analytical method transfer/validation process validation laboratory testing and laboratory investigations.
PHYSICAL/MENTAL REQUIREMENTS
Laboratory and office work require walking standing and sitting throughout a shift. The job has minimal lifting but may have extensive sitting and walking time. The ability to concentrate for long periods of time is necessary.
This is a penicillin manufacturing facility. All candidates applying must NOT be allergic to penicillin.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Non- Standard work schedule at times maybe required to support product release including weekend second shift night shift work / call for process decisions.
Minimal travel for training/seminars.
Relocation support available
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. Pfizer also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Required Experience:
Manager
Key Skills
- Laboratory Experience
- Quality Assurance
- Construction Experience
- FDA Regulations
- ISO 9001
- Assays
- Quality Systems
- Quality Control
- Quality Management
- cGMP
- QA/QC
- HACCP
About Company
Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.
