Lead Investigator
Lead Investigator
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Use Your Power for Purpose
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 Achieve
You will help with investigation of quality issues in manufacturing and quality laboratories. You will investigate manufacturing deviations out-of-specification results and atypical results. Your problem-solving skills will help to identify root cause and suggest an appropriate corrective action plan. Your attention to detail will help ensure that the reports are aligned to regulatory requirements and company policies. Your knowledge and skills will contribute towards the goals and objectives of the team by managing moderately complex projects along with managing your own time to meet targets. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams. It is your hard work and commitment that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
The position will be responsible for completing investigations in the site investigations electronic system as part of the mAbs Investigations team as the responsible person coordinating CAPA and driving to on time closure of investigations. In addition you will use your knowledge of other electronic systems used at the site including eQMS PDOCs gLIMS SAP PLA EAMS MS Office tools.
Also you will:
- Perform investigations for manufacturing related deviations utilizing Method 1 DMAIC tools (fishbone diagrams 5 whys process mapping) as needed to perform root cause analysis.
- Interact and coordinate with appropriate personnel including internal departments outside vendors bacterial/viral development QA regulatory (US/Japan/EU/China) and Qualified Persons during the investigation process
- Facilitate cross-functional and cross-site team meetings to perform a thorough investigation. Ability to identify root cause present complex problems with possible solutions and actively take leadership role to resolve investigation-related issues.
- Assess the impact of events on products equipment or processes. Communicate with management for all discrepancies that may impact product and delay disposition or shipments.
- Propose solutions to identified problems determine corrective actions and continuous improvements and assign commitments to facilitate implementation of solutions.
- Track trend and evaluate previous events and assess CAPA effectiveness and impact to current investigation.
- Draft investigation reports using strong technical writing skills to assure clear concise summaries product impact assessments and related commitments.
- Collaborate with QA to close investigations and assign responsibility for CAPA commitments.
- Ability to receive feedback from management and other colleagues take accountability for actions and personal development.
- Support regulatory and internal audits by being able to discuss and defend previous investigations.
- Strong understanding of cGMP Data Integrity and ALCOA principles.
- Execution and management of multiple initiatives at the same time and good communication skills to provide updates on investigation status to area management.
- Manage investigations and apply relevant and necessary actions/ systems to ensure appropriate levels of compliance.
Here Is What You Need (Minimum Requirements)
- Applicant must have a bachelors degree with at least 2 years of experience;
- OR a masters degree with 0 years of experience;
- OR an associates degree with 6 years of experience;
- OR a high school diploma (or equivalent) and 8 years of relevant experience
- Relevant experience with cGMP in a biopharmaceutical or pharmaceutical environment.
- Experience in technical writing
- Time management and organizational skills
- Proven record of problem-solving and decision-making skills
- Background and knowledge in manufacturing compliance and technology investigations processes and systems
- Must be comfortable working both independently and collaboratively
- Effective communication skills are required both written and verbal
- Computer literate
Bonus Points If You Have (Preferred Requirements)
- Knowledge and experience in Six Sigma and Lean methodologies
- Experience with completing investigations within a quality tracking system (QTS/ eQMS).
- Experience with FDA and EU licensing and inspection
- Experience with project management
- Experience using Documentum systems (such as PDOCS) laboratory information management systems (such as LIMS) learning management systems (such as Plateau PLS P2L) inventory management systems (such as SAP) and asset management systems (such as EAMS) are highly desired.
- Proficiency with Microsoft Office
- Excellent organizational skills
- Strong interpersonal skills and the ability to foster a collaborative team environment
PHYSICAL/MENTAL REQUIREMENTS
- Position requirements are typical for an office-based work environment with some shop floor exposure.
- Perform mathematical calculations and ability to perform complex data analysis
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
- Schedule is primarily day shift (M-F 8 hrs) but may require off-shift work on occasions.
- The position requires to adhere to all safety policies and procedures along with cGMP regulatory requirements internal Standard Operating Procedures (SOPs) and Pfizer policies and standards.
- Travel for this position is minimal to none.
Work Location Assignment:On Premise
Relocation Assistance Available: NO
The annual base salary for this position ranges from $80300.00 to $133900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.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.
Employment Type
Full-Time
