About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company 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. the company, 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.
The position will support the company 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; LIMS Master Data analyst functions, analyzing, interpreting, and trending results/data; creating, reviewing, executing activates for, and approving documentation; participating in 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.
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
• capability of detailing requirements for LIMS builds and building and testing new LIMS builds and LIMS Master Data changes
• 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 the company 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 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 information
• method 1, yellow belt trained and/or 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 the company procedures, policy and standards; quality systems knowledge; technical experience; 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 information 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
• expertise with investigations quality system and able to independently handle complex investigations and associated CAPA within own work area under limited guidance
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; Lean Six Sigma concepts; Lean Labs; project 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 the company values and our OWNIT culture
Performs tasks associated with maintaining cGMP compliant Quality Control and Stability laboratories.
• Responsible for detailing requirements for LIMS builds and building and testing new LIMS builds and LIMS Master Data changes.
• 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 (validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, the company standards, policies, and values.
• Responsible for reporting issues to management and participating in issue resolution (such as reporting deviations and participating in associated investigations, reporting instrument issues and assisting with troubleshooting, etc.)
• Responsible for contributing to 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
The minimal education and experience is as follows:
• 5-7 years of manufacturing, quality, engineering, or computer sciences type experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
• 2-4 years of manufacturing, quality, engineering, or computer sciences type experience in the biotech or pharmaceutical industry with a MS Degree 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.
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.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.
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