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 Assurance activities associated with clinical and/or commercial product, raw materials, validation, and stability. Key responsibilities are performing Quality final authorization/approval/release of cGXP documentation/equipment/processes; plans and executes complex projects; suggests improvements and conducts continuous improvement activities; and provides guidance/coaching to less experienced colleagues.
The individual should be able to demonstrate the following:
• Has sufficiently broad depth of knowledge of GXPs to be a key contributor or may be able to lead continuous improvement to a process or improve business efficiencies.
• Can identify and implement new processes and programs for quality improvement.
• Contributes to the interpretation of cGXPs for the commercial and clinical environment.
• Quality lead on large projects and contributes to the setting of validation strategy.
• Independently review working instructions/global procedures for technical content across multiple subject areas, with reference to applicable GXPs and regulatory expectations make value-added comments. Interfaces with other parts of the organization such as the company research and development groups. Able to work outside immediate subject area, supporting a wider range of customers of differing subject areas and locations.
• Able to resolve complex issues with minimal assistance from management. Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.
• Reviews trending reports and influences /agrees actions with key stakeholders.
• Provide guidance/coaching to less experienced colleagues.
• Interprets and understands complex data and forms conclusions and next steps based on findings with minimal assistance from management.
• Provides interpretation of data and reports.
• Advises on more complex policy and procedures.
• May lead and approve complex investigation.
• Makes decisions that may involve complex quality and technical issues.
• Makes decisions that may impact project progression and timelines.
• Expertise with investigation of complex technical issues and able to independently handle investigations across cross-functional work areas.
• Coach/mentor other colleagues with investigations.
• Collaborates/independently engages with a wide range of co-workers, customers and management within the OpU to gather the input and background knowledge needed to complete assignments.
• Anticipates issues and elevates them to appropriate management attention immediately.
• Demonstrates sound judgment on decisions that may involve technical issues.
• Able to assess internal and external compliance with applicable regulations.
• Trains colleagues on workgroup practices within area of expertise.
• Proactively and independently applies departmental best practices to work assignments.
• Able to recognize when such a multi-disciplinary discussion/issue is beyond their sphere of influence and escalates accordingly.
• Routinely demonstrate a good practice of technical exchange and open communication with team members. Participates in and may take a lead in decision making process.
• Team Involvement: Assigned as the Quality member of the project team empowered to speak for the Quality organization to other areas. Provides strategic input to accomplish team objectives. Established interpersonal skills (negotiation, managing conflict) to influence the team.
• Manage workload to meet established timelines.
Individual should have knowledge of US, EU, and ROW cGXP, Microsoft Office™ applications specifically Word and PowerPoint; Lean Six Sigma concepts; and Quality Risk Management.
Preferred experience with; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Systems, Applications, and Products (SAP)
Preferred experience with Laboratory Test Method, Cleaning, Process, Equipment and Automation Validation.
Responsible for knowing, understanding and acting in accordance with cGXPs, the company values and our OWNIT culture
Providing Quality Review/Oversight of site cGXP documentation related to the operation of a vaccine manufacturing facility/laboratory to ensure compliance with global regulatory agencies and the company quality standards.
Responsible for final authorization/approval/release of documentation/equipment/processes.
Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility.
Plans and leads projects to ensure their timely completion.
Provide guidance/coaching to less experienced colleagues.
Organizes and provides written and/or oral presentations of work with minimal input.
The minimal education and experience is as follows:
• 3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
• 0 -3 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work schedule primarily weekday first shift but 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.
A little about us:
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