Posted in Other 30+ days ago.
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Type: Full Time
Location: Wilmington, North Carolina
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.
The Senior Quality Specialist is accountable for driving results in a fast-paced laboratory environment by effectively performing activities of significant variety and complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing and approving laboratory related investigations, software validations, instrument/equipment qualifications, change controls, SOPs and other documents, 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 regulatory inspections and provide support during regulatory inspections. The position provides guidance and mentoring for other 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.
* Performs quality review and approval of laboratory related investigations.
* Performs quality review and approval of software validations
* Performes quality review and approval of laboratory equipment qualifications and change controls
* Review and approval of SOPs.
* Performs quality review and approval of other laboratory documents, protocols, and/or reports.
* Maintains quality databases and may perform analysis and trending.
* Provides consultation on 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.
* Serves as an effective member of the Quality team and may serve as a mentor to other laboratory Quality employees in the area of expertise.
* 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 8+ years GMP laboratory related experience, or Master's degree in related field with 4+ years related experience, or equivalent educational and work experience.
* Chromatographic experience preferred.
* 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
* Passion for customers. Understands Alcami customers. Gets to the heart of the matter. Uses that insight to provide value.
* Thinks strategically. Quickly identifies and acts on opportunities. Combines forethought with action. Understands the external and internal environment and the impact on Alcami.
* Acts decisively. Makes and acts on decisions quickly. Fosters the same in others and the courage to enhance risk-taking for the business.
* Drives performance. Holds self and others accountable. Creates an environment that enables others to perform at their best.
* Works collaboratively. Actively creates and promotes cross-boundary collaboration to achieve better results.
* Develops organization and people. Demonstrates genuine commitment to develop self and others.
* 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 mentor.
* Ability to act independently.
* Ability to interact well with employees at all levels.
* Ability to host audits.
* Proficiency with Microsoft Office products.
* 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.