Change Control Technical Writer

Change Control Technical Writer

Consultant I

Who We Are:

Born digital, UST transforms lives through the power of technology. We walk alongside our clients and partners, embedding innovation and agility into everything they do. We help them create transformative experiences and human-centered solutions for a better world.

UST is a mission-driven group of 29,000+ practical problem solvers and creative thinkers in more than 30 countries. Our entrepreneurial teams are empowered to innovate, act nimbly, and create a lasting and sustainable impact for our clients, their customers, and the communities in which we live.

With us, you'll create a boundless impact that transforms your career-and the lives of people across the world.

Visit us at UST.com.

You Are:

The CC Tech Writer will ensure compliance by coordinating Change Controls associated with supplier and raw materials changes to primary and secondary packaging, API's, and excipients impacting company internal and external sites.

The opportunity:

* The CC Tech Writer will initiate EtQ system CC requests to be communicated to internal and external manufacturing, testing and packaging sites with input from Sourcing, Supplier Quality, Site Leaders, Quality, and other Subject Matter Experts (SMEs) as needed.

* The CC Tech Writer will present CC Requests at Change Control Committee (CCC) Meetings and interface with the CC approvers to align CC wording, requirements and deliverables as needed to facilitate approval process.

* As part of this role, the CC Tech Writer will track/monitor CCs through their lifecycle. This includes, but is not limited to timely promotion & notification of change in status, regular updates to CC owners (Sourcing, Site Leaders, Quality & SMEs) on CCs and deliverable status, weekly monitoring and reporting of change control metrics including submissions, approvals and closures.

* This role will coordinate deliverables execution and documentation in CC as deliverables are received and ensure CCs are closed in a timely manner or initiate extensions when necessary if target closure date is not attainable.

* In some cases, the CC Tech Writer will need to act as a project manager and facilitate team meetings to ensure that changes are implemented to meet business needs.

This position description identifies the responsibilities and tasks typically associated with the performance of the position. Other relevant essential functions may be required.

What you need:

* A Bachelor's Degree is required. A focus degree in Science or Engineering Technologies is preferred.

* A minimum of 4 years of experience in a GMP regulated environment (pharmaceutical etc.) is required.

* A technical writing background is preferred.

* Experience with pharmaceutical or consumer manufacturing (processing/packaging, etc.) is required.

* Experience with facilities, validation, analytical sciences, microbiology or engineering is preferred.

* The ability to handle multiple, at times complex change controls at one time is required.

* The ability to read, analyze and interpret common scientific and technical documents is required. Project management, organizational skills and the ability to adapt to a fast-paced environment with changing priorities is preferred.

* The ability to effectively present information and communicate clearly to all levels of management is required.

* The ability to work directly with internal and external manufacturing sites under limited supervision is preferred.

* Knowledge of computer systems and proficiency with Microsoft Office Suite of programs (Word and Excel is required, Visio, Project, PowerPoint, and Access skills are preferred).

* Previous experience working in cross functional matrix environment with an ability to influence without authority is required.

* Knowledge of six sigma, process improvement or lean is preferred. Individual must demonstrate the following: detail and goal oriented, work in a team environment, customer-focus, ability to manage multiple projects, prioritize and adapt to business needs, have a thorough understanding of compliance requirements, effective verbal and written communication skills, interdependent partnering, strong decision-making/analysis skills, problem-solving and Lean mindset.

Compensation can differ depending on factors including but not limited to the specific office location, role, skill set, education, and level of experience. UST provides a reasonable range of compensation for roles that may be hired in various U.S. markets as set forth below.

Role Location: New Jersey

Compensation Range : $88,000-$132,000

Benefits

Full-time, regular employees accrue a minimum of 10 days of paid vacation per year, receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year), 10 paid holidays, and are eligible for paid bereavement leave and jury duty. They are eligible to participate in the Company's 401(k) Retirement Plan with employer matching. They and their dependents residing in the US are eligible for medical, dental, and vision insurance, as well as the following Company-paid Employee Only benefits: basic life insurance, accidental death and disability insurance, and short- and long-term disability benefits. Regular employees may purchase additional voluntary short-term disability benefits, and participate in a Health Savings Account (HSA) as well as a Flexible Spending Account (FSA) for healthcare, dependent child care, and/or commuting expenses as allowable under IRS guidelines. Benefits offerings vary in Puerto Rico.

Part-time employees receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year) and are eligible to participate in the Company's 401(k) Retirement Plan with employer matching.

Full-time temporary employees receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year) and are eligible to participate in the Company's 401(k) program with employer matching. They and their dependents residing in the US are eligible for medical, dental, and vision insurance.

Part-time temporary employees receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year).

All US employees who work in a state or locality with more generous paid sick leave benefits than specified here will receive the benefit of those sick leave laws.

What we believe:

We proudly embrace the values that have shaped UST since day one. We build our culture of Humility, Humanity, and Integrity. These values inspire us to nurture a people-first, human centric culture that fosters diversity, prioritizes sustainable solutions, and keeps our people and clients at the forefront of all decisions.

Humility:

We will listen, learn, be empathetic and help selflessly in our interactions with everyone.

Humanity:

Through business, we will better the lives of those less fortunate than ourselves.

Integrity:

We honor our commitments and act with responsibility in all our relationships.

Equal Employment Opportunity Statement

UST is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other applicable characteristics protected by law. We will consider qualified applicants with arrest or conviction records in accordance with state and local laws and "fair chance" ordinances.

UST reserves the right to periodically redefine your roles and responsibilities based on the requirements of the organization and/or your performance.

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change management,change control,validation,technical writing,