Manufacturing & Quality Specialists

Job Description

Job Description

We are seeking experienced Manufacturing and Quality professionals to support operations within highly regulated pharmaceutical, biotechnology, and medical device environments. This is an excellent opportunity for candidates who enjoy working in fast-paced settings, collaborating with cross-functional teams, and driving continuous improvement initiatives.

Preferred Qualifications:

• Bachelor's degree or higher in Engineering, Biotechnology, Life Sciences, Biology, Chemistry, or a related scientific discipline.
• 4+ years of directly related experience supporting manufacturing operations within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries.
• Knowledge of bioprocessing operations, Drug Substance manufacturing, and manufacturing support activities.
• Experience with process monitoring, investigations, CAPA management, Change Control, process validation, and Root Cause Analysis (5 Whys, Fishbone, Kepner-Tregoe, or similar methodologies).
• Experience performing Electronic Batch Record (EBR) review, approval, and reconciliation.
• Ability to provide Quality Assurance oversight and support manufacturing investigations, non-conformances, and issue resolution activities.
• Familiarity with Lean Manufacturing, Kaizen, Lean Six Sigma, and continuous improvement initiatives.
• Working knowledge of cGMP regulations, Good Documentation Practices (GDP), and compliance requirements.
• Experience working with manufacturing and quality systems, including SAP, TrackWise, Veeva, MES, PAS-X EBR, Smartsheet, CDOCS, Power BI, Spotfire, Microsoft Copilot, and ChatGPT.
• Strong analytical, troubleshooting, technical writing, and organizational skills.
• Excellent verbal and written communication skills in both English and Spanish.
• Proven ability to work independently, collaborate with cross-functional teams, and manage multiple priorities in a dynamic manufacturing environment.
• Flexibility to work extended hours based on business needs.

If you are passionate about manufacturing excellence, quality compliance, and continuous improvement within a regulated industry, we encourage you to apply.