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Senior Associate Scientist, Qc Bioanalytics

Company

Pfizer
Address , Sanford, Nc
Employment type FULL_TIME
Salary
Expires 2023-06-24
Posted at 1 year ago
Job Description
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, validation, and stability. 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.
At a minimum, the individual should be considered able to demonstrate the following:
  • Support training of new staff within immediate team; mentoring and coaching junior colleagues
  • Applies discipline’s principles and appropriate procedures to design and execute work against work group goals
  • Makes good decisions based on knowledge of quality systems/technical experience and work is accurate with little to no errors
  • Capability of solving complex mathematical and situation dependent problems
  • Acts safely and follows all EH&S safety requirements for site and QC laboratories
  • Experience assisting with laboratory investigations to define root cause and assisting with validation protocol non-conformances
  • Understanding of own area of function and knowledge of other cross functional areas
  • Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments
  • Increased ability to communication effectively with good interpersonal skills; establish relationships within Quality lines
  • Good written and verbal communication techniques
  • Ability to receive feedback and take accountability for actions and personal development
  • Understands the importance of feedback and receives feedback well from management and other colleagues
  • Method 1, yellow belt trained and/or understands use of tools and can apply them to solve issues (including technical issues)
  • Sufficient depth of knowledge within their scientific discipline and previous area of experience
  • Desire to ensure correctness and accuracy in tasks and documentation, detail oriented
  • Awareness to know their own limitations and seek senior scientist or management guidance when appropriate
  • Able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching
  • Fitness of functioning as a team member and performing independent work with minor guidance
  • Ability to follow written procedures and learn from hands on training
  • Interacts with business lines and shares information with team; capable of influencing and negotiating with business lines
  • Aptitude for good decision making based on procedures, guidance, and experience
  • Responsible for personal timelines delivery and seeks advice if conflicts arise
  • Willingness to use personal skills and knowledge to achieve individual and company goals and objectives
  • Recognizes the impact of procedural changes that may impact future quality tasks and decisions
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.
How You Will Achieve It
Responsible for knowing, understanding and acting in accordance with Pfizer’s values and our OWNIT culture
  • May perform data trending activities and assist with metrics reporting.
  • Assessing existing situations and suggesting improvements to increase compliance and innovation.
  • 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.
  • Performs tasks associated with maintaining GMP compliant Quality Control and Stability laboratories. Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
  • Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance.
  • Responsible for appropriate creation, review and approval of GMP documentation (test records, and as assigned validation protocols/reports, test methods, equipment records, etc.) and ensuring adherence to Pfizer standards, guidelines and values.
  • Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS result and participating in associated laboratory investigation, reporting instrument issues and assisting with troubleshooting, etc.)
Qualifications
  • Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.
  • Understanding of laboratory practices, analytical testing and use of analytical equipment: i.e. PCR, ELISA, endotoxin as well as other immunobiological assays.
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 may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.
Limited travel for the position; no more than 10% traveling.
Last Date to Apply for Job: Jan 6, 2022
Eligible for Relocation Package: No
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
Quality Assurance and Control