Quality Specialist

at Alcami (view profile)
Location Germantown, WI
Date Posted May 5, 2019
Category BioPharma
Job Type Full-time
Address W130N10497 Washington Dr

Description

Position Summary

The Quality Specialist is accountable for driving results in a fast-paced environment by effectively performing the activities as directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and inspections and maintaining quality databases. The position assists with the development of SOPs or other quality documents as needed. 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

  • Performs quality review and approval of documents, data, basic protocols, and/or reports.
  • Performs basic quality floor audits and/or floor inspections.
  • Provides quality evaluation and release of support materials, and intermediate products as required.
  • Maintains quality databases.
  • Assists with quality improvement initiatives as needed.
  • Assists with development of SOPs or other quality documents as needed.
  • Maintains accurate files and records.
  • 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 2+ years GMP 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

  • Knowledge of regulations and SOPs applicable to area of responsibility.
  • Good written and oral communication skills.
  • Good math skills.
  • Good computer skills and knowledge of Microsoft Office products.
  • Ability to interact well with employees at all levels.

 

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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