Pfizer Quality Sr.Associate Scientist in Sanford, North Carolina
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.
For Grade level 4, 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, detail oriented
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
support training of new staff within immediate team; mentoring and coaching junior colleagues
able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching
experience assisting with laboratory investigations to define root cause and assisting with validation protocol non-conformances
method 1, yellow belt trained and/or understands use of tools and can apply them to solve issues (including technical issues)
understands the importance of feedback and receives feedback well from management and other colleagues
makes good decisions based on knowledge of quality systems/technical experience and work is accurate with little to no errors
recognizes the impact of procedural changes that may impact future quality tasks and decisions
applies discipline's principles and appropriate procedures to design and execute work against work group goals
able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments
responsible for personal timelines delivery and seeks advice if conflicts arise
interacts with business lines and shares information with team; capable of influencing and negotiating with business lines
increased ability to communication effectively with good interpersonal skills; establish relationships within Quality lines
Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical chemistry and/or Microbiology techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.
Responsible for knowing, understanding and acting in accordance with Pfizer's values and our OWNIT culture
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.)
Assessing 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.
- 4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
A BS/BA Degree in Science/related field with experience in biotech or pharmaceutical industry is preferred; however, other appropriate combinations of education and/or experience in the biotech or pharmaceutical industry are suitable
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. Weekend work will be required.
Limited travel for the position; no more than 10% traveling.
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.
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.
- Last Date to Apply for Job: 20 July, 2018
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.