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QC Senior Scientist, Microbology


Sanford, NC
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Job Details

Job Title QC Senior Scientist, Microbology

JobID 1053668

Location: Sanford, NC

Description The position will support the Pfizer Sanford, NC Quality Control Microbiology 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 activities 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.

The individual should be considered 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 the QC Microbiology laboratory, in order to reliably support audits and to expertly review/approve technical content ensuring both scientific merit and compliance to regulatory agency regulations and able to apply Pfizer policy and standards, able to holistically review and authorize all laboratory data, and have an extensive overall knowledge of all laboratory operations

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

• ability to identify issues and present complex problems (including mathematical problems and situation-dependent multifaceted problems) with possible solutions, and actively takes team leadership or independent role to resolve, even in situations with only ambiguous information, help aid in solution of complex issues (using yellow belt certification/tools), implements unique approaches to problem solving, and may coach others to become yellow belt 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

• good judgment, detail oriented behavior, and correct decision making that includes impact awareness on future quality and compliance as well as impact on own work group, department, site/network, and global impact awareness, based on expert or gained knowledge of Pfizer procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations

• 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 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

• uses other Pfizer Divisions information to obtain new ideas and/or benchmarking against when replicating best practices or new processes, as well as contributes to site and Network Quality Operation related strategies and decisions

• capable of metric setting, tracking, trending, evaluating, drawing conclusions from for improvements and actions, and reporting for the Quality Operations, site, and/or Network

• works well in ambiguous space

• capable of managing a highly complex and/or high impact business system or product from the Quality Organization perspective

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/or Stability laboratories.

• May perform testing including, but not limited to clinical and/or commercial product, raw materials, validation/qualification, stability, and EM samples. Trains junior colleagues and may develop training plans and/or oversee training activities for groups.

• 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 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 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.

• 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 initiating, leading 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

• Responsible for improving and automating existing and developing methodologies and new technologies, implement business process enhancements, measure and respond to business process improvements.

• Author, review, and approve documentation such as, procedures, forms, protocols/reports, risk assessments, and trend reports; provide input, for investigations, commitments, and change controls to ensure changes/CAPAs are robust and will be effective.

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.

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

For grade level 12, the minimal education and experience is as follows:

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

• 7 -8 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field

• 2 -4 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.


Predominately standard business hours with some exceptions on weekends and nights to meet business needs of 24/7 manufacturing facility.

Limited travel for the position; no more than 15% traveling.

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: 25 August, 2017**

+ **This job is (Pfizer) (Exempt) (US/PR) Grade: 012**

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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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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