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QC Senior Scientist


Sanford, NC
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Job Details

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, stability and environmental monitoring. Key responsibilities are performing GMP tasks/activities associated with maintaining compliant Quality Control and Stability laboratories; analyzing, interpreting, and trending results/data; creating, reviewing, executing activates for, and approving documentation; participating in and/or leading investigations of events/OOS results; designing, organizing, and/or conducting assay development/automation/troubleshooting/method transfer/validation activities, acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations; represents and makes decisions for Quality Control on cross functional teams; leads projects and/or teams providing guidance/training/coaching to junior colleagues; and conducting project management for site and network projects.

For grade level 10, the individual should be able to demonstrate the following:

+ acting safely, knows and follows all EH&S safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely

+ recognized as a Subject Matter Expert having extensive technical knowledge of assays and instrumentation used within QC

+ reliable to support audits and to expertly review/approve technical content ensuring both scientific merit and compliance to regulatory agency regulations and Pfizer policy and standards

+ excellent effective written and verbal communication and interpersonal skills; established relationships within business lines

+ ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve or independently resolves complex issues

+ applies discipline's principles, appropriate procedures, and leadership skills to develop action plans and contributes to executing toward individual, team, and project goals

+ expertly solving highly complex mathematical problems and solving situation dependent multifaceted problems using even only ambiguous information

+ at least method 1, yellow belt certified, applies method 1 tools to solve complex issues, implements unique approaches to problem solving, and coaches others to become method 1 certified

+ receives feedback well from management and other colleagues, grows self utilizing feedback and takes accountability for actions and personal development

+ collaborate/independently engage with a wide range of co-workers, customers and management within the Network to gather the input and background knowledge needed to complete assignments

+ consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail oriented behavior

+ good judgment and correct decision making based on expert knowledge of Pfizer procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations

+ decision making that includes impact awareness on future quality and compliance as well as impact on own work group, department, and site

+ represents Quality Control on site and network teams/forums/summits that support sustaining or improving site or network operations; influences and negotiates with business lines and shares information obtained with Quality Operations

+ influential change agent fostering continuous improvement behaviors in others

+ proactively identifies, takes remedial action, and/or seeks advice when a personal, project, team, department, or Network goal/deliverable is off schedule

+ delivery on large and complex high business impact projects/activities/changes

+ able to holistically review and authorize all laboratory data, and have an extensive overall knowledge of all laboratory operations

+ able to design/create, organize execution, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records; assist with protocol non-conformance evaluations

+ able to identify and seek out external resources (e.g. PDA, ISPE) to build or enhance understanding of scientific discipline; actively supports training of staff; understands the importance of and mentors and coaches junior colleagues; seeks mentor for self

+ displays strong investigative or technological orientation with independence for design of projects/studies and makes significant independent contributions to the development/improvement/trouble shooting of methodology including new technologies and automation

+ expertise with the investigations quality system and able to independently handle complex investigations and determine associated CAPA with no guidance

+ capability of detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes

Individual should have knowledge of US, EU, and ROW cGMP; pharmacopeias; ICH guidelines; analytical chemistry and/or Microbiology techniques and instrumentation, Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Microsoft Office applications specifically Word, Excel, and PowerPoint; statistical software such as JMPTM and MinitabTM; Lean Six Sigma concepts; Lean Labs; project management tools including stakeholder management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.

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

Performs tasks associated with maintaining and improving cGMP compliant Quality Control and Stability laboratories.

Analyzes and interprets QC results, makes decisions regarding the accuracy, completeness and compliance; performs data trending; evaluates trending reports and influences / agrees actions with key stakeholders.

Responsible for reporting issues to management and leading issue resolution or independently resolving issues (such as reporting OOS results, participating in/leading associated laboratory investigations, reporting instrument issues and assisting with/conducting/leading troubleshooting activities, etc.).

Responsible for appropriate design, review, approval and final authorization of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process technology transfer activities, documents for regulatory filings, regulatory filings, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values.

Responsible for improving and automating existing and developing methodologies and new technologies.

Responsible for detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes.

Responsible for significantly contributing to and/or leading laboratory investigations for events and OOS results. Evaluates and approves the best CAPA for root cause to eliminate repeat events.

Serves on cross functional teams to represent Quality Operations and facilitate communications and activities/projects between Quality Operations and site departments and/or Network. Serves as technical SME for the QO in these interactions and makes decisions on Quality Operations behalf.

Responsible for initiating, leading a working groups and/or manage projects/changes to accomplish change activities/project deliverables and whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines

Trains junior colleagues and may develop training plans and/or oversee training activities for groups.

Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation.

May manage a business system (e.g. manages LIMS system, stability system) or product from the Quality Organization perspective

May perform testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability, and EM samples.

For grade level 10, the minimal education and experience is as follows:

+ 8 -10 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field

+ 5 -7 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field

+ 0 -1 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a Ph. D in Science/related field

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.

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 15% 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.

**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.

+ **Last Date to Apply for Job: 15 November, 2017**

+ **This job is (Pfizer) (Exempt) (US/PR) Grade: 010**

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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