Pfizer Quality Sr. Associate Scientist in Sanford, North Carolina

About Pfizer

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description

Position is primarily focused on QC Microbiology testing (in-process, stability, and release testing as well as environmental and utilities monitoring), with additional responsibilities for troubleshooting, continuous improvement, and basic project management. Cross-functional training and responsibilities within the Quality Organization may be required.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, at a minimum, the individual should be 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 techniquesability 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 areassupport training of new staff within immediate team; mentoring and coaching junior colleaguesable to create, review, and approve test method and/or equipment validation records with limited guidance/coachingexperience assisting with laboratory investigations to define root cause and assisting with validation protocol non-conformancesmethod 1, yellow belt trained and 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 colleaguesmakes good decisions based on knowledge of quality systems/technical experience and work is accurate with little to no errorsrecognizes the impact of procedural changes that may impact future quality tasks and decisionsapplies 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 ariseinteracts 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 linesIndividual 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.

Responsibilities

Responsible for knowing, understanding and acting in accordance with Pfizer's values and our OWNIT culturePerforms 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.

Qualifications

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.4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.DESIRABLE: University Degree in the field of Engineering, Microbiology, Chemistry, Biotechnology, Biochemistry or Pharmacy or other appropriate education and experience in biotech or pharmaceutical industry is preferred. Technical QC / Microbiological experience preferred. Knowledge / application of aseptic technique is essential.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/cabinetsIntellectual 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.

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 Sr. Associate Scientist Sanford, North Carolina 1043097