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Quality control scientist iv | Quality Control, Scientist in Quality Assurance Job in Sanford NC |1

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Quality control scientist iv

Sanford, NC

ROLE SUMMARY 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. Critical responsibilities are performing GMP tasks/activities associated with maintaining compliant Quality Control and Stability laboratories; testing; analyzing, interpreting, and trending results/data; creating, reviewing, executing activates for, and approving documentation; participating in and/or leading investigations of events/OOS results; acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations; represents Quality Control on cross functional teams; and leads projects and/or teams providing guidance/training/coaching to junior colleagues; assists in regulatory and internal audits. This position is focused on Microbiological assays. Background in bioburden, viable count method (serial dilution), sterility, microbial identification, and culture purity is preferred. Analyst would be a Lead Analyst responsible for ensuring routine testing is scheduled, completed, and reviewed within the required time frame. Analyst would be available for trouble shooting and to direct/coach junior analysts. Other responsibilities would include SOP revisions, qualification/validation support, as well as represent QC Microbiology in meetings and during internal and regulatory audits. 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 "go-to" person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pfizer policy and standards excellent effective written and spoken communication and people skills; established relationships within business lines ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve of issues applies discipline's principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals solving highly complex mathematical problems and situation dependent problems using convoluted details method 1, yellow belt trained and can apply tools to solve issues (including technical issues) ability to receive feedback from management and other colleagues, takes accountability for actions and personal development consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail oriented behavior good judgment and correct decision making based on Pfizer procedures, policy and standards; quality systems knowledge; technical background; and industry guidance / regulatory authority regulations; decision impact awareness on future quality and compliance as well as impact on own work group, department, and network represents Quality Control on site and network teams/forums that support sustaining or improving site or network operations; influences and negotiates with business lines and shares info obtained with team; acts as change agent for improvements proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule delivery on 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 create, 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; supports training of staff; mentoring and coaching junior colleagues displays strong investigative or technological orientation with independence for design of projects/studies and able to make significant independent contributions to the development of methodology including new technologies and automation ability with investigations quality system and able to independently handle complex investigations and associated CAPA within own work area under limited 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 Details Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Microsoft office suite™ applications specifically Ms word, Microsoft excel, and PowerPoint; Lean 6 Sigma concepts; Lean Labs; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments. ROLE RESPONSIBILITIES Responsible for knowing, understanding and acting in accordance with Pfizer's values and our OWNIT culture Performs tasks associated with maintaining cGMP compliant Quality Control and Stability laboratories. Performs testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability, and EM samples. Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance; performs data trending Responsible for appropriate creation, review, approval and final authorization of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values. Responsible for detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes. Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS results and participating in associated laboratory investigations, reporting instrument issues and assisting with troubleshooting, etc.) Responsible for contributing to and/or handle laboratory investigations for events and OOS results. 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. Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network. May initiate, lead a working group and/or manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines. REQUIREMENTS The minimal education and background is as follows: • 5-7yrs of manufacturing, quality or engineering background in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related position • 2-four years of manufacturing, quality or engineering background in the biotech or pharmaceutical industry with a MS Degree in Science/related position PHYSICAL/MENTAL REQUIREMENTS Ability to lift 30lbs, stand for two to 3 hours at a time, sit for two 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 1st, 2nd, and/or 3rd shift hours as appropriate for assigned tasks/activities. Limited travel for the position; no more than 10% traveling. 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 info 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 candidates 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. Last Date to Apply for Job: six December, 2019 Eligible for Employee Friend referral bonus Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Quality Assurance and ControlFor more details:
December 5 2019 on Jobs-Search
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