- Hologic (Marlborough, MA)
- …record of successfully completing internal and external audits within FDA-regulated cGMP facilities. + Demonstrated experience in building and promoting a culture ... of quality that drives employee engagement and exceptional customer experiences. **Why join Hologic?** We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we… more
- AbbVie (Worcester, MA)
- …+ Must also be familiar with AbbVie Quality Systems as well as cGMP and other regulatory requirements. + Strong communication Skills, both oral and written ... Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: + The compensation range described below is the range of possible base pay compensation that the Company… more
- Takeda Pharmaceuticals (Boston, MA)
- …Engineering or Pharmaceutical Engineering. + At least 5+ years' experience in a cGMP environment. + At least 5+ years of pharmaceutical industry experience in small ... molecules is preferred. + Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience. + Strategic enterprise thinking, finding innovative ways to serve patients build… more
- AbbVie (Worcester, MA)
- …systems. + Ensure all automation systems comply with regulatory requirements (FDA, cGMP , etc.). + Mitigates risk within functions through sound design, early risk ... assessments and implementation of fallback strategies. + Recommend and implement business strategies and engineering controls to reduce costs, increase efficiency, and drive world-class performance. + Develop and manage staff through hiring, managing… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and validation activities. **How you will contribute:** + You will perform cGMP manufacturing operations. + Standard Operating Procedures (SOP), Batch Records and ... Form + Troubleshoot and escalate process related issues Create work orders + Initiate and document minor deviations + Execute critical, routine and non-routine production operations + Inform management of events impacting schedule + request and execution of… more
- Rhythm Pharmaceuticals (Boston, MA)
- …assessments, sampling plans, shelf-life reports. + Awareness of ICH, compendial, cGMP and pharmaceutical best practices. + Familiarity with analytical and ... characterization procedures. + Familiarity with eQMS applications such as Veeva. + Competent in the use of software applications, including statistical applications, stability trending, task management. + Excellent interpersonal, organizational,… more
- Jacobs (Boston, MA)
- …power systems * Lab. and Vivarium Design * Life Science/ Pharmaceutical cGMP manufacturing #LI-AD2 Jacobs is an Equal Opportunity/Affirmative Action Employer. All ... qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or… more
- Danaher Corporation (Shrewsbury, MA)
- …control, risk management.) required; 6-8 years preferred + Extensive experience with cGMP and/or ISO 13485 including documentation, audit, nonconformance and CAPA + ... Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English It would be a plus if you also possess previous experience in: + Experience with supporting change control systems (ECR / ECO) and risk… more
- Burns & McDonnell (Newton, MA)
- …management of change orders. + Applies knowledge and understanding of FDA, cGMP , and other concepts, practices, codes, and procedures within the industry. + ... Demonstrated ability to develop designs in new or renovated facilities which integrate equipment, processes, and people. + Experienced in developing Process Architect deliverables across the Life Sciences industry including but not limited to Animal Health,… more
- Takeda Pharmaceuticals (Boston, MA)
- …process development activities. + Understanding of current Good Manufacturing Practices ( cGMP ). **Knowledge and Skills:** + Analytical and Problem Solving Skills - ... Able to troubleshoot critical issues or problems, and determine causes and possible solutions + Teamwork -- Ability to work well in highly cross functional team environment and across global line functions. + Communication Skills -Able to expresses one's self… more
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