JOB TITLE: Sr.QA Specialist
Location:New Brunswick,NJ
Duration:11 months contract
JOB DESCRIPTION:
- Coordinate, develop, and manage a robust process relating to material qualification and certification for the network.
- Execute and improve network procedures for Client's sites globally. This may requires revisions to procedures for managerial review and approval and drafts documentation where appropriate.
- Train on multiple procedures/processes, and provide support to a wider spectrum of stakeholders in the network.
- SME in multiple aspects of documentation and supplier quality management (i.e. vendor management, supplier scorecard, quality agreements, approved supplier list, material qualification, reduce testing, etc.)
- Knowledgeable of laboratory reduce testing and material qualification. Primary resource for material qualification and certification support.
- Support supplier investigations and trending as needed.
- Act as Quality lead on assigned projects.
Skilled in writing, reviewing supplier quality agreements and master supplier agreements
Knowledge of science generally attained through studies resulting in a BS in the physical or life sciences, chemistry, supply chain, a related discipline, or the equivalent in related experience.
- 4-7 years of experience in Supplier Quality, cGMP Biologics QC laboratory or related cGLP or cGMP environment.
- Proficiency (or mastery) of methodologies within QC (i.e. reduce testing, qualification, etc.) and supplier quality (i.e. investigation, non-conformances, corrective actions, agreements, etc.)
- Attention to detail and demonstrated organizational skills.
- Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.
- Proficiency in applying cGMP regulations and compendial testing required.
- Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
Demonstrates leadership, and independent problem solving and analytical thinking skills.
Proficiency with common computer software applications (email, MS Office, etc.) and lab based computer applications LIMS, ELN, Maximo or similar, DeltaV or similar, and Infinity or similar. Will work in teams and have continual interaction with members of his/her team as well as other sub-teams within QA/QC in order to exchange information regarding supplier quality and reduce testing as it relates to meeting department goals and objectives
Daily contact with her/his manager for work assignments. Routine contact with manager for coaching and general performance management discussions.
- Occasional contact with other management staff relating to specific project responsibilities may be expected.
- May represent Quality in cross functional teams or projects.
- Cross-site/vendor communications as needed for strategic purposes
- May be required to coordinate with site stakeholders for troubleshooting purposes relating to suppliers.
- Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing, laboratory, and/or project timeline
- Flexibility to work irregular hours and short notice overtime.
- Sr. Specialists should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending and implementing corrective actions.
- Incumbents normally receive little to no instructions on routine work and assist with the creation of detailed instructions on new assignments.
- May be expected to lead cross-functional project team.
- Sr. Specialist will be expected to participate in the training of less experienced personnel as well as assisting less experienced personnel in normal operational tasks.