QC Scientist
QC Scientist
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$ 66500 - 110900
1 Vacancy
Job Description
Use Your Power for Purpose
Every day everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture which is both science and riskbased is flexible innovative and customeroriented. Whether you are engaged in development maintenance compliance or analysis through research programs your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the needs of those we serve. By being part of our team you play a crucial role in maintaining this high standard and making a difference in the lives of patients.
What You Will Achieve
In this role you will:
- 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 compliant Quality Control and Stability laboratories.
- Represent Quality Control Analytical in cross functional and site product meetings.
- 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 Reporting issues to management and participating in issue resolution.
- Train junior colleagues develop training plans and oversee training activities for groups.
- Provide subject matter expertise for standard operating procedures and quality standards content as well as providing gap analysis to ensure that the microbiological finished product laboratories stay 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 nonconformance investigations related to manufacturing and stability.
- Review and approval of data in Laboratory Information Management System for lot release.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelors degree with 3 years OR a masters with 0 years of experience.
Demonstrated experience in manufacturing quality or engineering within the biotech or pharmaceutical industry
Solid understanding of aseptic laboratory techniques and quality systems
Ability to establish strong relationships within business lines
Excellent written and verbal communication and interpersonal skills
Proficiency in laboratory information management systems and data analysis software
Strong problemsolving skills and attention to detail
Experienced with analytical lab equipment (FTIR Microscopes etc.)
Bonus Points If You Have (Preferred Requirements)
Experience in Quality Operations
Familiarity with regulatory requirements and compliance standards
Ability to work independently and as part of a team
Strong organizational and time management skills
Ability to adapt to changing priorities and work in a fastpaced environment
Experience defending laboratory practices in regulatory audit.
Working knowledge of organic chemistry including degradation mechanisms of pharmaceutical active ingredients and pharmaceutical products
Use of microscopes (i.e Scanning Electron Microscope) Raman Technology (i.e. Hound) and/or FTIRs
Particulate/Particle Identification expertise
Physical/Mental Requirements
Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition must be able to appropriately identify and escalate issues on a timely basis.
NonStandard Work Schedule Travel or Environment Requirements
Schedule is 1st shift Monday Friday. Must be able to work on weekend off shifts and holiday as business demands. Travel <10%.
Work Location Assignment:On Premise
OTHER JOB DETAILS
- Last Date to Apply for Job: May 21st 2025
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: NO
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 EVerify employer. This position requires permanent work authorization in the United States.
Employment Type
Full-Time
