About TSR :
TSR is a relationship-based, customer-focused IT and technical services staffing company.
For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.
Mission & Vision
- We do not believe in building a vision around the company but building a company around our vision, which is simply;
Every employee's voice matters, their effort is appreciated, and their talent is rewarded.
We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.
Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.
Specialist, QA Engineering
Job Description
Location : Warren, New JerseyType : ContractJob #81369Our client, a leading pharmaceutical company, is hiring a QA Lead, on a contract basis.
Job ID # : 81369
Work Location :
Warren, NJ - Hybrid role
Summary :
This role is responsible for providing quality oversight on technology transfer into and out of the site, process understanding and enhancement, and other site qualification activities in a fast-paced, highly collaborative manufacturing facility. This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
Education / Experience :
B.S. degree required.Six years of experience in the pharmaceutical or related industry.Equivalent combination of education and experience acceptable.Knowledge / Skills :
Must have strong understanding of global cGMP, quality systems (especially change management), and guidance documents.Must have knowledge of technology transfer for manufacturing processes.Must routinely anticipate, recognize and resolve quality issues with minimal direction from management. Inform management of proposed solutions on complex issues.Must be able to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Must be able to fully interpret complex results and situations independently and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally.Must be action-oriented, customer-focused, skilled in decision-making, build relationships, good at problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.Work is self-directed.Must effectively communicate and interact with management and stakeholders with clarity and accuracy.Understands fundamental scientific problems.Must have strong quality background.Responsibilities :
QA lead on technology transfer activities (process) :Ensure technology transfers on new product introduction and / or new trials and cohorts are compliant with internal standards and / or regulatory requirements, as applicable.Maintain knowledge of scientific literature, regulatory guidelines, internal standards / procedures and apply key concepts during project activities / plans.Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.Interact and collaborate with cross-functional teams to achieve common goals.Provide training to QA colleagues on new product manufacturing process, as applicable to ensure clinical production readiness.Must be knowledgeable on change control process.Must be knowledgeable on the process and associated methods for the assigned product.Support Product / Program Lifecycle Management ActivitiesSupport change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.Review media simulation activities to ensure successful execution and documentation.Maintain data integrity by ensuring procedures / processes are compliant with internal data integrity standards and procedures.Work with Engineering / Facilities / Warehouse / Supply Chain / Manufacturing Operations / Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.Ensure procedures are adequate to review and confirm appropriateness of data.Display Leadership QualitiesCreate an environment of teamwork, open communication, and a sense of urgencyPromote a mindset of continuous improvement, problem solving, and preventionDrive strong collaboration within the site and across the networkBuild trust and effective relationships with peers and stakeholdersDrive improvements to remove inefficiencies, improve quality and optimize productivity.Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.Reporting RelationshipReports to Senior Manager, QA Engineering
