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Job: Sr. Quality Specialist, Alcami, Wilmington, NC

General Information

Job title:
Sr. Quality Specialist
Job location:
Wilmington, NC  28405 United States
Requisition code:
Date posted:
Job category:
Employment type:
Full time

Job Description

Position Summary

The Senior Quality Specialist is accountable for driving results in a fast-paced environment by effectively performing activities of substantial variety and complexity to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility.  These activities include reviewing documents and data, conducting 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 serves as quality host for client and regulatory agency audits and inspections.  The position develops SOPs or other quality documents as needed.  The position provides guidance and mentoring for other Quality employees. Serve as a back-up to site Quality Management for technical Quality decision making.  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

  • Serves as Quality host for client and regulatory agency audits and inspections.

  • Serves as back-up to site Quality Management for technical Quality decision making.

  • Performs quality review and approval of complex documents, all types of data, protocols, and/or reports.

  • Performs quality floor audits and/or floor inspections.

  • Provides quality evaluation and release of support materials, products, equipment and facilities as required.

  • Maintains quality databases and may perform analysis and trending.

  • Assists with quality improvement initiatives as needed.

  • Develops quality SOPs or other quality documents and/or reports as needed. 

  • Provides consultation on complex quality and compliance topics in areas of expertise.

  • Develops and provides training in quality and compliance topics in areas of expertise.

  • Serves as client quality liaison and/or quality host of client audits; coordinates responses to client audits.

  • Effectively performs a variety of complex duties, on schedule, with accuracy and competency.

  • Maintains accurate files and records.

  • Serves as an effective member of the Quality team and serves as a mentor to other Quality employees in the area of expertise.  

  • Performs other duties as assigned.

  • Complies with company policies and SOPs.

  • 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 10+ years of GMP related experience, or Master’s degree in related field with 5+ years of related experience, or equivalent educational and work 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

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

  • Good written and oral communication skills.

  • Good math skills.

  • Good computer skills and knowledge of Microsoft Office products.

  • Ability to be trained and to mentor.

  • Ability to act independently.

  • Ability to interact well with clients and regulatory agents.

  • Ability to negotiate.

  • Ability to interact well with employees at all levels.

  • Ability to host audits.

  • Ability to act as technical consultant.


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: 3959769)
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