Bioanalytical Testing Lab Staff Colleague
- Employer
- Pfizer
- Location
- Kalamazoo, Michigan
- Start date
- Jul 30, 2021
View more
- Discipline
- Science/R&D, Research, Laboratory
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will AchieveYou will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing biological or microbiological products to support our quality programs. Your contribution to bioanalytical testing will help Pfizer provide safe drugs to patients.
Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D.
As a Scientist, your deep knowledge in the discipline, will make you an active team member who influences at the project team level. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.
It is your knowledge and skills that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It- Contribute to achievement of goals at the work group/ project team level as a full team participant.
- Perform tasks associated with maintaining {Current} Good Manufacturing Practices {part of GxP} for compliant Quality Control laboratories.
- Represent Quality Control Bioanalytical testing labs in cross functional and site product meetings.
- Interact with other team members within the Microbiology Department and with team members from other departments, primarily within the Quality and Drug Product organizations.
- Interface with many levels of the organization including Laboratory Technicians, Staff Microbiologists, Production Operators, Quality and Operations Management, and eventually internal and external Regulatory Auditors.
- Interpret data and make recommendations and reach decisions based on data and management input.
- Apply existing techniques and procedures, with recommendations, and implementation of modifications for improved efficiency, or devise and develop new microbiological techniques and procedures and participate in issue resolution.
- Train junior colleagues, help develop training plans and oversee training activities for groups with unit training coordinator.
- Provide subject matter expertise for standard operating procedures and quality standards content, as well as providing gap analysis to ensure that the program is compliant with all regulatory requirements.
- Support change controls, investigations and other technical documents.
- Participate in regulatory filing writing in sections related to analytical method and stability testing.
- Conduct and review non-conformance investigations related to testing of materials in lab.
- Bachelor's Degree and 6+ years' of relevant experience
- Experience using laboratory information management systems and quality tracking systems
- Expertise with development, optimization, and validation of PCR, ELISA, Gel electrophoresis, blood and cell-based assays, and various protein/nucleic acid binding assays.
- Demonstrated independent accomplishment of complex bioanalytical method development and validation.
- Ability to recognize atypical data, inform supervision of relevant problems, and implement solutions.
- Ability to receive feedback and takes accountability for actions and personal development.
- Excellent effective written and verbal communication and interpersonal skills.
- Basic computer skills, such as data entry, with a high level of attention to detail, are also required.
- Master's degree and 4+ years of relevant experience
- Experience with flow cytometer, capillary gel electrophoresis, and coagulation assays highly desirable.
- Experience with GMP.
- Experience leading continuous improvement projects
- Experience defending laboratory practices in regulatory audit.
- Experience using Lean, Six Sigma, and other continuous improvement methodologies for process improvement is highly desirable.
PHYSICAL/MENTAL REQUIREMENTS
Job duties may involve sitting for extended periods while working at computer terminal.
Job will involve extended periods of working at a lab bench or in a biosafety hood.
Must have good analytical skills and ability to interpret chromatograms, electropherograms, and spectrophotometer output.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Job may require working off shift at times, and/or some travel.
Other Job Details:
Eligible for Relocation Assistance: Yes
Eligible for Employee Referral Bonus: Yes
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