CDMO, CMO, Contract Development and Manufacturing Organisation

Quality Assurance Intern

Job Title
Quality Assurance Intern
Location
Germantown,  WI 53022
Other Location
Description
About Sterling
Sterling Pharma Solutions has over 50 years' experience serving the global pharmaceutical industry. With facilities in Dudley, UK, Cary, North Carolina, and Germantown, Wisconsin, our state-of-the-art facilities, proprietary technologies and experienced people are among the best in the industry. We have a proven track record in the supply of chemistry and analytical services across the entire API lifecycle, from grams to tons, from pre-clinical to commercial supply. We pride ourselves on our customer focus and service approach, offering flexible, tailored solutions to our clients.

Summary of Role
The Quality Intern will collaborate with Sterling Germantown Quality Assurance or Regulatory Affairs employees in one or more or these areas: Quality Operations, Compliance, Document Control, Engineering Quality, Computerized System Validation, and Regulatory Affairs. Examples of activities are:
  • Processing of executed manufacturing, cleaning, and testing records
  • Revision and formatting of standard operating procedures and work instructions
  • Compilation and analysis of manufacturing and testing data and quality metrics
  • Auditing of warehouse, manufacturing, and laboratory areas for compliance with company SOPs and regulations
  • The Quality Intern will receive training on Good Documentation Practices, Good Manufacturing Practices, and pharmaceutical regulations such as ICH Q7 and will gain experience in their application in pharmaceutical manufacturing and testing.
  • 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.

Education and Requirements
  • Enrolled in a 4-year college or university pursuing a Bachelor’s degree in science or engineering.
  • Excellent verbal and written communication and documentation skills required.
  • Excellent detail orientation and organizational skills required.
  • Excellent problem-solving and basic trouble-shooting ability required.
  • Awareness or prior work experience in a GMP environment preferred.
  • Candidates need to be competent with IT systems and Microsoft Office including Outlook, PowerPoint, Word, and Excel.
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.

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