QA Specialist, Client Services Allendale, NJ ref

QA Specialist, Client Services Allendale, NJ ref

Skills: Quality Assurance, Document management, issuance, investigation, CAPA, SOP, Qualification and Validation Reports
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Experience level: Associate Experience required: 5 Years Education level: Bachelors degree Job function: Quality Assurance Industry: Biotechnology Compensation: View salary Total position: 1 Relocation assistance: No Visa : Only US citizens and Greencard holders
This position reports to the Quality Assurance Manager. Responsible to perform Quality Assurance activities in support of Quality Systems and/or client procedures including but not limited to client specific document management, issuance, investigation, CAPA, creating/updating SOPs, Qualification and Validation Reports, etc. Attends project kick off meeting, as well as weekly project meeting. Participate in to tech transfer activity. Represent quality department during client meetings. Work with trifunctional department to ensure project related activity is completed on time. This role supports internal and external audits which may include interaction with Health Authorities and clients.

Essential Functions and Responsibilities

Below is the summary of the role responsibilities. This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.

Attends project kick-off meetings to understand the scope of the project.

Creates, updates, reviews and/or approves project related documents such SOPs, Batch release templates, label templates, batch records, change controls, etc. according to client requirements and project scope.

Participates in tech transfer activity to ensure adherence to company quality system standards.

Proactively identifies risk and prepares mitigation strategies associated with project and client work.

Represents QA Client Services during scheduled meetings with client and cross functional department.

Ensures all necessary quality documents are closed prior to batch released; responsible for batch released on timely manner according to schedule. (link removed)>
Participates in client meetings and monitor quality activities of internal team members as they relate to contract deliverables.

Draft initial Quality agreement and complete necessary revisions based on client and company requirements.

Promptly and effectively communicates any successes, challenges, and/or constraints internally and externally with clients as appropriate.

Provides quality data to Project Manager for the purpose of creating KPI metrics.

Builds rapport with clients and troubleshoots issues of concern with internal team in order to provide the highest quality services which meet the needs and requirements of our clients. Updates and maintains accurate information for each client on project-related documentation repository (i.e., SharePoint).

Communicates internally within QA team to provide key updates on project status, timelines, and deliverables.

Formulates and prioritizes appropriate responses to client requests or concerns.

Trains Quality Associates on client specific processes to ensure records are complete, accurate and submitted by agreed deadline.

Supports, participates and follows up appropriately to internal, regulatory agency and client audit requests on a timely basis.

Identifies and supports continuous improvement opportunities working cross departmentally or cross functionally n order to enhance operations.

Other duties may be assigned

Qualifications

Bachelor's Degree in Life Sciences

Minimum 5 years experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred.

Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required.

Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.

Familiar with FDA, ISO, and other regulatory agency guidelines.

Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required.

Working knowledge and technical understanding of aseptic manufacture of biologics preferred.

Experience in both clinical and commercial manufacturing is preferred.

Experience participating health authority inspections and/or client audits preferred.

Experience in organizing teams for effective and timely completion of projects.

Competencies/Candidate Profile

Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.

Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.

Decision Quality: Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.

Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.

Composure: Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress; is not knocked off balance by the unexpected; doesnt show frustration when resisted or blocked; is a settling influence in a crisis.

Learning on the Fly: Learns quickly when facing new problems; a relentless and versatile learner; open to change; analyzes both successes and failures for clues to improvement; experiments and will try anything to find solutions; enjoys the challenge of unfamiliar tasks; quickly grasps the essence and the underlying structure of anything.