Job description

We are looking for a QA Deviation Reviewer who will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations. 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.

Job Responsibilities:

• Supports all activities for the Quality Operations Investigations group.
• Provide quality oversight of Manufacturing Operations, QC Chemistry and QC Microbiology.
• Work with manufacturing and laboratory management to ensure activities comply with global regulatory requirements.
• Ensure procedures are adequate and confirm appropriateness of raw data.
• Review and approve manufacturing and QC laboratory investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
• Ensure the site is compliant with global and regulatory data governance and data integrity requirements.
• 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.

Job Requirements:

• 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 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 note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
• 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.
• Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching others and analytical thinking.
• Must possess an independent mindset and tenacity.

Job Type: Contract

Pay: $95.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Summit, NJ 07901: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you have experience in pharmaceutical industry?
• What is your Work Authorization?

Experience:

• Quality Control and/or Quality Assurance: 6 years (Preferred)

Work Location: In person

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