Associate Scientist, QC Chemistry
Pfizer
Why Patients Need You
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
The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, and validation. Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; testing, analyzing, interpreting, and trending results; and creating, reviewing and approving documentation.
Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.
At a minimum, the individual should be considered able to demonstrate the following:
Acts safely and follows all EH&S safety requirements for site and QC laboratories
Sufficient depth of knowledge within their scientific discipline and previous area of experience
Good written and verbal communication techniques
Ability to follow written procedures and learn from hands on training
Capability of solving complex mathematical and situation dependent problems
Ability to receive feedback and take accountability for actions and personal development
Aptitude for good decision making based on procedures, guidance, and experience
Awareness to know their own limitations and seek senior scientist or management guidance when appropriate
Desire to ensure correctness and accuracy in tasks and documentation
Fitness of functioning as a team member and performing independent work with minor guidance
Willingness to use personal skills and knowledge to achieve individual and company goals and objectives
Understanding of own area of function and knowledge of other cross functional areas
Able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching
Understands the importance of feedback and receives feedback well from management and other colleagues
Makes good decisions based on knowledge of quality systems and technical experience
Recognizes the impact of procedural changes that may impact future quality tasks and decisions
Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations
Responsible for personal timelines and seeks advice if conflicts arise
Interacts with business lines and shares information with team; capable of influencing and negotiating with business lines
Ability to communicate effectively with good interpersonal skills
How You Will Achieve It
Performs testing including, but not limited to, clinical product, commercial product, raw materials, and validation samples.
Analyzes and interprets results, makes decisions regarding the accuracy, completeness, and compliance.
Creates, reviews and approves GMP documentation (test records, and as assigned validation protocols/reports, test methods, equipment records, etc.) while ensuring adherence to Pfizer standards, guidelines and values.
Reports issues to management and participates in issue resolution, such as reporting OOS results, participating laboratory investigations, reporting instrument issues, troubleshooting instruments, etc.
Assesses existing situations and suggesting improvements to increase compliance and innovation.
May perform data trending activities and assist with metrics reporting.
May initiate and develop project plans to ensure projects timely completion.
May serve on cross functional teams to facilitate communications between Quality Control and other departments.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
Fundamental understanding of laboratory instrumentation function and analytical testing and use of analytical equipment.
Aptitude for good decision making based on procedures, guidance, technology, and experience
Effective communication skills
Knowledge of Microsoft Office applications, specifically Word and Excel
Bonus Points If You Have (Preferred Requirements)
A deep understanding of Chemistry testing and experience in defending laboratory practices during regulatory audits
2+ years of QC Chemistry Laboratory experience
1+ years of HPLC experience
Proficiency in both viable and non-viable environmental monitoring within pharmaceutical manufacturing
Solid grasp of aseptic techniques
Strong problem-solving skills
Computer programing knowledge
Ability to work independently and as part of a team
Ability to manage multiple tasks simultaneously
PHYSICAL/MENTAL REQUIREMENTS
Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.
Intellectual capability to perform complex mathematical problems and perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work schedule 4 days a week 10 hours each day. Sunday to Wednesday (8:30 am to 7:00pm) but can include other weekdays and/or weekend days as appropriate for assigned tasks/activities Minimal off-shift work to ensure business needs are met.
Not expected to travel.
Must be able to wear appropriate PPE (e.g., lab coat, safety glasses, non-porous shoes, gloves, ect.)
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 provider’s 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 www.pfizer.com/careers accessible 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 disabilityrecruitment@pfizer.com. 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.