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Document and Data Management IV at Alcami Corporation in Morrisville, North Carolina

Posted in Other 30+ days ago.

Type: Full Time





Job Description:

Think Different. Do Different. Be Different.

Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.

Position Summary

The Document and Data Management Support IV is accountable for driving results in a fast-paced environment by providing administrative support related to documentation system requirements. The ideal candidate will maintain documentation and files to assure they are accurate and up-to-date and available to appropriate personnel. The position maintains systems providing change control for master documents. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

- Audits document files to ensure compliance with external and internal quality assurance requirements.

- Maintains accurate and up-to-date documentation manuals and files.

- Applies advanced skills in procedures, techniques, tools, materials and/or equipment appropriate for area of specialization.

- Resolves extremely complex questions and problems.

- Aids in training other support personnel.

- Determines methods and procedures on new assignments and may provide guidance to less experienced personnel.

- Acts independently to determine methods and procedures on new assignments.

- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

- High School Diploma or equivalent with a minimum of 6-8 years of related work experience; OR

- Associate's Degree with 4-6 years of related experience.

Alcami Non-Negotiables

- Consistently demonstrates honesty and integrity through personal example.

- Follows all safety policies and leads by example a safety first culture.

- Produces high quality work product with a focus on first time right.

- Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

- Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.

- Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.

- Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.

- Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.

- Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.

- Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

- General working knowledge of word processing, reports and presentation creation.

- Good verbal and written communication skills.

- Works well in team setting.

- Ability to perform complex math functions, compute ratios, rates, and percentages.

- Ability to draw and interpret graphs and charts.

- Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.

- General working knowledge of cGMP procedures and safety regulations.

- Computer proficient with working knowledge of Microsoft Office software.

Travel Requirements

- Up to 5% travel required.

What We Offer You:

- Competitive salary with career advancement opportunities

- Profit sharing bonus plan

- Medical, dental and vision coverage from day one

- 401(k) with company match

- Company paid vacation, holiday and sick-leave

- Voluntary benefits including short & long term disability, life, accident, critical illness insurances

Diversity and Inclusion:

Alcami values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

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