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Job: Quality Specialist III, Alcami, Morrisville, NC

General Information

Job title:
Quality Specialist III
Job location:
Morrisville, NC  27560 United States
Requisition code:
Date posted:
Job category:
Employment type:
Full time

Job Description

Position Summary

The Quality Specialist III of Laboratory Quality position is responsible for performing detailed review of test results and associated data generated by the Alcami Laboratory groups for compliance with cGMP, internal SOPs and Specifications. This position will also support other Quality aspects of the laboratory including equipment qualification, deviation/investigation review and approval, CAPA planning, equipment qualification and SOP review and approvals. The Quality Specialist III must have good organizational skills and be able to manage multiple tasks with competing priority.

The Quality Specialist III is accountable for driving results in a fast-paced environment by effectively performing activities of significant variety and complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting more complex, process-focused audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed.  The position may serve as quality host for client audits and inspections and provide support during regulatory inspections. The position assists with the development of SOPs or other quality documents as needed and may provide guidance and mentoring for other Quality Services employees in areas of expertise. 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

  • Review lab equipment calibration records and log-books, and other review functions as needed.

  • Perform review and approval of laboratory equipment qualification, deviations/investigations, CAPA, and Standard Operating Procedures and other Quality documents.

  • Work with other departments and Quality management to facilitate continuous improvement for both laboratory and Quality processes.

  • Assist with technical writing and review of procedures, complex protocols, and reports.

  • Performs complex quality floor audits and/or floor inspections.

  • Provide support to management in other data-related tasks such as guardianship of matrixes and KPI.

  • Performs related duties as assigned.


Education and Experience

  • Bachelor’s degree in Chemistry, Biology, or related field.

  • Pharmaceutical laboratory experience including at least six years in GMP QA/QC/Compliance.

  • Experience with Waters HPLC/UPLC, Empower software, and ELN preferred.

  • Working knowledge of laboratory Microbiology testing desired.

  • Organized and detail-oriented.

  • Ability to multitask in a fast-paced environment.

  • Experience with Nonconformance/Deviation and CAPA programs.

  • Experience in laboratory equipment qualification and method validation desired.

  • Experience in protocol-driven work.

  • Ability to work independently, along with the ability to work well within a team, and willing to work overtime or off schedule as needed to meet demands of Center.

  • Ability to communicate effectively, both orally and in writing.

  • Knowledge of GMP documentation, procedures, and systems as related.

  • Excellent computer skills (Microsoft Word and Excel).


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

  • Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.

  • Excellent written and oral communication skills.

  • Good math skills.

  • Ability to be trained and to mentor.

  • Ability to act independently.

  • Ability to interact well with employees at all levels.

  • Ability to host audits.

  • Proficiency with Microsoft Office products.


Travel Requirements

  • Up to 5% travel required.


Job Requirements

(see job description above)
(Job number: 4046590)
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