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Job: Data Comp Specialist II, Alcami, Wilmington, NC

General Information


Job title:
Data Comp Specialist II
Job location:
Wilmington, NC  28405 United States
Requisition code:
Date posted:
11/11/2020
Compensation:
Job category:
Other
Employment type:
Full time

Job Description


Position Summary



The Data Compilation Specialist II is accountable for driving results in a fast-paced environment by reviewing content and quality of final client reports from laboratory documentation.  The ideal candidate will ensure that laboratory data is reported in accordance with company SOPs or client requirements and work closely with data reviewers and management to expedite/correct data.  The ideal candidate will assure client-specific reporting requirements are met.  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




  • Reviews and approves content and quality of final client reports from laboratory documentation.

  • Ensures laboratory data is reported in accordance with company SOPs or client requirements.

  • Works closely with data reviewers and management to expedite/correct data.

  • Ensures laboratory investigation and deviation notes are referenced for inclusion on final reports.

  • Reviews stability data for trending patterns.

  • Responsible for accurate and timely data entry.

  • Review Lab Generated reports for format

  • Performs peer reviews of reports as needed.

  • Monitors late reports to expedite project closure.

  • Reviews ERP documents to monitor priorities and due dates.

  • Assists with Quality improvement initiatives as needed

  • Trains new employees.

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



 



Education and Experience




  • Bachelor’s degree in Chemistry, Biology or related field with 3+ years of related experience preferred.

  • Associate’s degree in a scientific field 4+ years of related experience preferred.



 



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




  • Knowledge of GMP/Regulatory procedures.

  • Familiarity with lab notebooks.

  • Knowledge of the Company’s SOPs.

  • Computer proficient including Microsoft Office software.

  • Problem solving skills.

  • Good oral and written communication.

  • Works well in a team environment.



 



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



 

Job Requirements


(see job description above)
(Job number: 3958132)
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