Quality Specialist III
Company: Alcami Corporation
Posted on: October 12, 2019
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
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
* Performs quality review and approval of documents, all types of
data, protocols, and/or reports.
* Performs complex quality floor audits and/or floor
* Provides quality evaluation and release of support materials,
products, equipment and facilities as required.
* Maintains quality databases and may perform analysis and
* Assists with quality improvement initiatives as needed.
* Assists with development/ writing of SOPs or other quality
documents and/or reports as needed.
* Provides consultation on quality and compliance topics in areas
* Provide training in quality and compliance topics in areas of
* Serves as client quality liaison and/or quality host of client
audits; coordinates responses to client audits.
* Maintains accurate files and records.
* Serves as an effective member of the Quality team and may serve
as a mentor to other Quality employees in the area of
* Performs other duties as assigned.
* Complies with company polices and SOPs.
* Ensures timely completion and compliance with cGMP and all other
relevant company training requirements.
Education and Experience
* Bachelors degree in Chemistry, Biology, or related field with 6+
years GMP related experience, or Masters degree in related field
with 2+ years related experience, or equivalent educational and
* Consistently demonstrates honesty and integrity through personal
* Follows all safety policies and leads by example a safety first
* Produces high quality work product with a focus on first time
* Complies with the company code of conduct and policies and
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
* 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
* 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
* Passion for customers. Listens to understand. Asks the right
questions. Gets to the heart of the matter and uses that insight to
* 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.
* 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.
* 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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Keywords: Alcami Corporation, Wilmington , Quality Specialist III, Other , Wilmington, North Carolina
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