CDMO, CMO, Contract Development and Manufacturing Organisation

Quality Specialist I

Job Title
Quality Specialist I
Germantown,  WI 53022
Other Location

Summary of role

The Quality Specialist I 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 Sterling 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.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Education and Experience

  • Bachelor’s degree in Chemistry, Biology, or related field with 2+ years GMP related experience, or equivalent educational and work experience.

Key Competencies

  • Knowledge of regulations and SOPs applicable to area of responsibility.
  • Good written and oral communication skills.
  • Good math skills. 
  • Ability to interact well with employees at all levels.
  • Candidates need to be competent with IT systems, and Microsoft Office including Outlook, PowerPoint, Word and Excel.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. 
  • Duties, responsibilities and activities may change at any time with or without notice. 

Diversity and Inclusion

Sterling 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.
Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day. 

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