Quality Assurance Specialist (Branchburg, NJ - Hybrid) (Must Have an experience with Pharmaceutical or Biotech Industry exp)
Sharp Decisions Inc. is seeking a qualified Quality Assurance Specialist to support our client in Branchburg, NJ. This is an onsite position. The initial contract term is 03 years, with a strong possibility of extension based on performance and project needs.
You will be responsible to
1. Drive business results and customer value
a. Responsible for performing activities as required to meet Q&R goals and objectives independently. Able to identify improvements and implement with collaboration from your manager.
b. Be recognized internally as an expert in your own job discipline with in-depth knowledge/skill-set of related disciplines in the field.
c. Act as a coach for colleagues with less experience and help them develop skills/expertise.
d. Document authoring and review as required to support changes. Performs technical reviews, as applicable. May require collaboration with supervisor on technically complex technical reviews independently.
e. Preparing documentation for and participating in audits as applicable.
f. Completing all required training in learning solution.
g. Responsible for training, coaching and mentoring other quality managers or business partners, as applicable in a professional manner to ensure that business needs are being met.
h. Able to troubleshoot issues as they arise, develop and independently implement solutions to ensure that daily work is completed without jeopardizing compliance.
i. Communicating significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.
2. Advance the work of the Network, making tradeoffs and breaking silos
a. Ability to work day to day with minimal to no supervision to correctly complete daily scheduled and unscheduled activities. Initiates activities independently and initiates interactions across departments as applicable. Initiates daily activities independently. Has courage to make decisions even outside of scope/comfort zone. Is decisive and does not procrastinate on decisions; develop solutions and present both issues and solutions to your manager.
b. Identify, Initiate, facilitate, participate and implement process improvements to meet business needs. Able to link responsibilities with both site and Global Quality and Regulatory. Drive innovation across the local organization/site.
c. Leads or contributes with skills to projects / squads within.
d. Participates in large/global cross-functional or cross-chapter projects.
e. Be involved in solving unique or unprecedented problems that have an impact on a part of the organization, function or chapter.
3. Empower and enable the Network
a. Build and maintain strong partnerships with colleagues and business patterns to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.
b. Be the champion and advocate for Engrained Quality at the Site.
c. Build a culture of continuous improvement.
4. Enable the organization's New Ways of Working
a. Act as role-model for Agile Leadership behaviors, as well as for our culture, mindset & behaviors as defined in the Dia Operating Principles
b. Model behaviors to support the organization's transformation to new, more Agile Ways of Working - e.g. new decision making/governance practices, collaboration, etc.
c. Everything you do should contribute directly to the achievement of our Ten Year ambitions, including:
Double patient access to novel, high-medical-value diagnostics solutions
Build the leading, profitable insights business
Improve patients' lives via 'One Approach' to ecosystem in every country
1. How
a. Know and follow the Dia Operating Principles and Core Competencies. Adopts and adheres to the Leadership Commitments. Accountable for meeting commitments. Is flexible and able to shift priorities while balancing commitments and daily work requirements, independently. Seeks candid feedback on his or her performance and acts on it. Recognizes the contributions of teammates and peers. Establishes strong collaborative relationships inter-departmentally and across the sites and leverages these connections to achieve our key results. Identifies personal goals and actively manages her or his career to pursue personal goals and priorities independently.
What else do you have in your toolbox:
3-5 years experience
Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience. Completed training as a technician or laboratory technician; or equivalent qualification for the tasks; limited working experience.
Has worked in more than one function within quality management and may have worked outside of Quality Management. Can managing highly complex and/or global projects, or equivalent experience.