Manufacturing Associate

Employment Type

: Full-Time

Industry

: Manufacturing




Manufacturing Associate

As a manufacturing Associate you will be 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.

  • 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. Hazardous waste training depending on specific requirements of 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.
  • Participate in and support continuous improvement, and LEAN initiatives. Recognize technical issues and relay to supervisor.
  • 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.
  • The following GSK values and expectations are key behavioral characteristics for this role: Patient Focus, Transparency, Respect, and Integrity, Courage, Accountability, Development, and Teamwork
  • Why you?

    Basic Qualifications:

    We are looking for professionals with these required skills to achieve our goals:

  • Bachelor’s degree and 1 year of cGMP/healthcare/lab related experience

    or

    High School Diploma/equivalent and 2 to 3 years of cGMP/healthcare/lab related experience.
  • Good oral and written communication skills. Ability to communicate effectively and project a professional image when giving/taking information in person, in writing, or over the phone. 

  • Understanding of Microsoft Office (MS Word, MS Excel, MS Outlook. 

  • Understanding of weights and volume measures as well as a general knowledge of bio-burden control techniques.

  • Ability to take initiative and prioritize tasks; good time management, problem prevention, and problem-solving skills

  • Strong understanding of cGMP and quality systems.

  • Strong understanding of Quality systems to include deviation and CAPA systems

  • Preferred Qualifications:

    If you have the following characteristics, it would be a plus:

  • Bachelor’s degree in Technical field

  • Ability to take initiative and prioritize tasks; good time management, problem prevention, and problem-solving skills

  • Other Job-Related Experience

  • 2 to 3 years of cGMP/healthcare/lab related experience with High School Diploma.

    or

    1 year of cGMP/healthcare/lab related experience with Bachelor’s degree
  • Ability to take initiative and prioritize tasks; good time management, problem prevention, and problem solving skills

    Basic understanding of cGMP and quality systems.
  • 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
  • -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
  • -Escalate issues and concerns (safety, quality, production) to supervisor
  • -Understand and adhere to cGMP requirements
  • -Independently operate production equipment per appropriate procedures
  • -Participate in all aspects of team functions and employ bioburden control techniques
  • -Identify and assist in mitigation of safety issues
  • -Participate in investigations both EHS and Quality related
  • -Participate 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
  • -Other duties as assigned by supervisor

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