Required Skills / Qualifications:
- Bachelor"s degree in Science or Engineering
- Minimum of 10 years" experience in Quality Assurance or Design Assurance in the Pharmaceutical, Biotech, or medical device industry (or related industry), or in related engineering areas, e.g. R&D or Manufacturing
Preferred Skills / Qualifications:
- Masters Degree
- Demonstrated experience working with sterile dosage forms in a sterile manufacturing environment.
- Experience with pre-filled syringes, blow-fill seal technology
- Experience with comparative Statistical techniques, sampling plans, GR&R, hypothesis testing, ANOVA, parametric and non-parametric analysis
- Extensive knowledge of quality tools:
- Validations and Qualifications
- Regulatory guidelines
- US Pharmacopoeias
- Internal auditing
- Handling of regulatory Inspections
- Well acquainted with QMS
- Well versed with Change control/deviations and market compliant management system
- Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (QDP); and ICH Q8, Q8, and Q10 procedures.
- Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE) strongly desired
- Proficiency with Microsoft Word, Microsoft Excel, and Power Point .
- Documentation skills.
- The ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required. This candidate must be a technical expert and have excellent written and oral communication and interpersonal relationship skills
- Will be an added advantage if the individual has dealt with multiple audits personally.
- Upon offer of employment, the individual will be subject to a background check and a drug screen.
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.