Senior Manufacturing Associate
188362 Senior Manufacturing Associate
- Perform duties as assigned with respect to quality, timeliness, quantity, and cost. Work individually and as a team to deliver cGMP compliant product. Adhere to GSK policies, procedures and support site goals. Complete documentation in line with regulatory, GSK, and departmental requirements. Work and communicate closely with other departments both inside and outside of the Value Stream.Train and mentor less experienced staff. Work with minimal supervision and coordinate complex tasks between departments. Oversee and coordinate equipment related task and issues. Demonstrate ability to cross train in multiple disciplines across the Value Stream and participate in cross functional teams. Takes initiative, provides accurate "right the first time" work and practices good time management in a fast paced, ever changing environment. Demonstrates an in-depth knowledge of the job. Assists in resource planning, organization and control of activities and produces a high quality and high volume of work.
- Responsible for application of GSK safety and environmental guidelines and act as a role model within the department. Ensure all job responsibilities are in compliance with applicable regulations, current operating procedures and industry practice. Identify and help mitigate EHS and safety risks. Work with supervisor to mitigate safety concerns and provide guidance for teammates related to safety topics. Hazardous waste training depending on specific requirements of the VS department.
- Ensure all activities are executed following quality and regulatory standards. Supports cross-functional communication and the GSK quality mindset by proactively identifying and reporting compliance issues to area supervisor or QA. Work with supervisor and QA to mitigate identified issues. Adhere to all GSK QMS policies and procedures applicable to functional area. Lead and facilitate the inspection readiness of the department.
- Support production planning to achieve VS objectives, including delivery to yearly manufacturing plan.
- Represent GSK with the highest level of integrity and professionalism. Ability to maintain confidentiality of sensitive information. Adhere to GSK policies and procedures and support management decisions and goals in a professional manner. Show awareness of changing schedules, request and priorities put forth by management. Hold self and teammates to applicable safety and quality standards. Support cross-functional communication both within and external to the department. Meet agreed timelines for task and escalate timeline adherence concerns to supervisor.
- The following HPB's are key behavioral characteristics for this job role: Set direction & inspire, Work across boundaries, Release energy, Develop capability & talent, Drive performance, and Live our values.
- Participate in and support continuous improvement, and LEAN initiatives. Recognize technical issues and relay to supervisor.
- High School Diploma or equivalent and 3 years of cGMP/healthcare/lab related experience
- Strong understanding of cGMP and quality systems including the ability to guide others in correct cGMP principles.
Strong understanding of Quality systems to include deviation and CAPA systems
- Bachelor's degree and 2 years of cGMP/healthcare/lab related
Other Job-Related Skills/Background
- Perform manufacturing/cleaning/sampling/processing steps in coordination with other manufacturing/QA/QC personnel
- Handling of hazardous waste from production activities to satellite storage areas. Annual training on area-specific hazardous waste handling as required. This training satisfies annual RCRA training requirement for large quantity generators and is part of the site's RCRA compliance program.
- Maintain and review training forms and files
- Participate in RCA for EHS incident and deviations
- Potentially responsible for aiding in writing and closing deviations.
- Participate in presenting and maintaining site in a state of inspection readiness
- Responsible for participation/writing/closure of CAPA tasks both safety and quality related
- Perform duties as per written procedures and maintain strict adherence to those procedures
- Ask for assistance and do not perform duties without appropriate training
- Attend all mandatory training and take a positive approach to compliance
- Work both independently and in a team environment
- Adapt to changing schedules, priorities, and requests from supervisor
- Understand and adhere to cGMP requirements
- Independently operate production equipment per appropriate procedures
- Proficient in all aspects of team functions and employ bioburden control techniques
- Identify and assist in mitigation of safety issues
- Lead investigations both EHS and Quality related
- Lead in risk assessments and L1 audits both EHS and Quality related
- Write and revise procedures/protocols
- Drive CAPA closure
- Identify and implement process improvements
- Maintain MBRs, logbooks, Room History Record, and other VS paperwork
- Maintain cGMP compliance in areas of responsibility and participates in internal and external audits
- Provide technical expertise in equipment
- Coordinate scheduling of equipment processing, maintenance, and calibration activities
- Assist VS Compliance team with area specific change control
- Work with TS and others to trouble shoot equipment issues
- Participate in preparation and maintaining areas of responsibility in a state of inspection readiness
- Other duties as assigned by supervisor
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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