Qa Deviation Reviewer Jobs

Hi,

I am Berkmans Clinton from Collab Infotech.

We have an immediate contract (W2) opportunity forQA Deviation Reviewer with a large Pharma company inSummit, New Jersey.Please find the details below. If this interests you, please share your updated resume to[email protected]or call me @+1 609-608-0589 for further details.

Position:QA Deviation Reviewer

Location:Summit, New Jersey- (Onsite)

Client: BMS

Duration: 6 months

Pay Rate: $90.11 /hr on W2

Experience Required: (4-7 Years)

:

This role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight for Manufacturing Operations and QC laboratories; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

• Initiatives and activities by interdisciplinary teams.
• Capable of providing input within the department and cross functional teams.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Work is self-directed.
• Must have advanced knowledge and experience with cGMP manufacturing, Quality, and Compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
• Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
• Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
• Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching other and analytical thinking.
• Able to write and review reports with clarity and brevity.
• Proposes solutions for complex issues and works with management to resolve.
• Understanding of aseptic manufacturing processes.
• Builds relationships internally within and with cross functional teams.
• Able to effectively multi-task and execute project management skills.
• Excellent verbal and written communication skills.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.
• Across a majority of the job function and manage development of technical or scientific
• Confident in making decisions for minor issues.
• Ability to interpret results and situations and articulate recommendations for resolution.
• Knowledge of US and global cGMP requirements.
• Follows established procedures and performs work as assigned.
• Provides guidance to other employees in interpretation of complex data.
• Routinely recognizes Quality issues and solves problems.
• Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
• Contributes to goals within the work group.
• Must possess an independent mindset and tenacity.
• Is recognized Subject Matter Expert within the group.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to recognize conflict and notify management with proposed recommendations for resolution
• Must provide guidance to other employees in the interpretation of technical/scientific issues

Education and Experience:

• B.S. degree required; advanced degree preferred. Minimum 5 years Quality Control and/or Quality Assurance experience in a pharmaceutical company with CAR T or Biologics experience preferred

Duties And Responsibilities:

• Supports all activities for the Quality Operations Investigations group.
• Ensure control of systems, processes and product through supporting review and approval of change notices and change control. Review site change controls and ensure appropriate requirements are identified and completed for implementation.
• Work with manufacturing and laboratory management to ensure activities comply with global regulatory requirements.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Establishes and maintains procedures to ensure data integrity is maintained and procedures/processes are compliant.
• Ensure site is compliant with global and regulatory data governance and data integrity requirements
• Review and approve manufacturing and QC laboratory investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Assess global standards/policies and emerging regulations.
• Able to effectively multi-task.
• Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
• Provide quality oversight of Manufacturing Operations, QC Chemistry and QC Microbiology.
• Ensure the site stability program meets global and regulatory requirements.
• Ensure procedures are adequate and confirm appropriateness of raw data.