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Form of work Position Details:
Our client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a GMP Quality Lab Manager / HYBRID WORK to join their expanding team.
Job Title: GMP Quality Lab Manager / Pharma Industry / HYBRID WORK
Duration: 9 months contract, extendable up to 36 months
Location: Sanford, NC
Hybrid Role: onsite 2-3 days/week
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GMP portfolio/programs/entities.
This role is responsible for GMP Oversight and for assuring the compliance of projects, products and programs with Pharmaceutical Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations, guidelines and standards (e.g., US FDA, EU Directives, National regulations, ICH, ISO)
Why Patients Need You -
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.
Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve -
You will be a member of Pharmaceutical's dedicated and highly effective quality operations team. This role supports the Pharmaceutical Sanford, NC Quality Operations department by performing Quality Assurance activities specific to Data Integrity (DI).
Key responsibilities are project management of DI assessments and resulting improvements, document revisions, approval of GMP tasks associated with maintaining compliance, and acting as a change agent and driving continuous improvement by mentoring colleagues in DI compliance.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and focus that will make Pharmaceutical ready to achieve new milestones and help patients across the globe.
How You Will Achieve It -
Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Suggest improvements and conduct continuous improvement activities.
Performs DI activities and tasks associated with maintaining cGMP compliance.
Assesses existing situations and suggesting continuous improvements to increase compliance and innovation.
Initiate, execute review, and approve DI activates for GMP tasks/activities ensuring adherence to regulatory agency requirements, Pharmaceutical standards, policies, and values.
Responsible for reporting issues to management and participating in issue resolution.
Serve on cross functional teams to represent QA and facilitate communications and activities/projects between QA and site departments.
Supports and prepares site for audits and regulatory inspections.
Performs other Quality Compliance functions as needed.
Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices
Comfortable interfacing with multiple laboratory software including but not limited to LIMS, Empower, Softmax Pro, 32 Karate, Tiamo, Image Lab, and WinUV.
Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
Qualifications:
Must-Have -
Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associate's degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.
Experience in Quality administered systems
Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
Proactive approach and strong critical thinking skills
Must be able to work in a team environment within own team and interdepartmental teams
Excellent communication and interpersonal skills
Good working knowledge of Microsoft Excel and Word
Nice-to-Have
Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener.
Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure.
PHYSICAL/MENTAL REQUIREMENTS
Lifting, sitting, standing, walking, bending, and training.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work Location Assignment: Flexible
Work Schedule: 8AM - 5PM
On-Site 3 days a week
Eligible for Shift Differential: NO
Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associate's degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.
Our client, a world-leading Pharmaceutical Company in Sanford, NC is currently looking for a GMP Quality Lab Manager / HYBRID WORK to join their expanding team.
Job Title: GMP Quality Lab Manager / Pharma Industry / HYBRID WORK
Duration: 9 months contract, extendable up to 36 months
Location: Sanford, NC
Hybrid Role: onsite 2-3 days/week
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GMP portfolio/programs/entities.
This role is responsible for GMP Oversight and for assuring the compliance of projects, products and programs with Pharmaceutical Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations, guidelines and standards (e.g., US FDA, EU Directives, National regulations, ICH, ISO)
Why Patients Need You -
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.
Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve -
You will be a member of Pharmaceutical's dedicated and highly effective quality operations team. This role supports the Pharmaceutical Sanford, NC Quality Operations department by performing Quality Assurance activities specific to Data Integrity (DI).
Key responsibilities are project management of DI assessments and resulting improvements, document revisions, approval of GMP tasks associated with maintaining compliance, and acting as a change agent and driving continuous improvement by mentoring colleagues in DI compliance.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and focus that will make Pharmaceutical ready to achieve new milestones and help patients across the globe.
How You Will Achieve It -
Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Suggest improvements and conduct continuous improvement activities.
Performs DI activities and tasks associated with maintaining cGMP compliance.
Assesses existing situations and suggesting continuous improvements to increase compliance and innovation.
Initiate, execute review, and approve DI activates for GMP tasks/activities ensuring adherence to regulatory agency requirements, Pharmaceutical standards, policies, and values.
Responsible for reporting issues to management and participating in issue resolution.
Serve on cross functional teams to represent QA and facilitate communications and activities/projects between QA and site departments.
Supports and prepares site for audits and regulatory inspections.
Performs other Quality Compliance functions as needed.
Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices
Comfortable interfacing with multiple laboratory software including but not limited to LIMS, Empower, Softmax Pro, 32 Karate, Tiamo, Image Lab, and WinUV.
Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
Qualifications:
Must-Have -
Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associate's degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.
Experience in Quality administered systems
Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
Proactive approach and strong critical thinking skills
Must be able to work in a team environment within own team and interdepartmental teams
Excellent communication and interpersonal skills
Good working knowledge of Microsoft Excel and Word
Nice-to-Have
Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener.
Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure.
PHYSICAL/MENTAL REQUIREMENTS
Lifting, sitting, standing, walking, bending, and training.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work Location Assignment: Flexible
Work Schedule: 8AM - 5PM
On-Site 3 days a week
Eligible for Shift Differential: NO
Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associate's degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.
