Quality Specialist (Pharmaceuticals)

TL;DR

Quality Specialist (Pharmaceuticals): Ensuring compliance with SOPs and regulatory requirements for pharmaceutical manufacturing with an accent on QMS implementation and CQV documentation. Focus on conducting readiness inspections, managing deviation investigations, and fostering a culture of GMP compliance during facility startup.

Location: On-site in Middletown, DE

Company

Global CRDMO leader enabling healthcare innovation worldwide.

What you will do

• Provide on-the-floor operational and manufacturing support to ensure SOP compliance.
• Implement the QMS at the new manufacturing site, documenting processes for solid oral dosage, API, and aseptic small molecule production.
• Review and approve facility, utility, and equipment CQV documentation (URS, FAT, SAT, IQ/OQ/PQ, and process validations).
• Conduct readiness inspections of manufacturing areas and computerized systems to mitigate quality risks prior to startup.
• Support deviation investigations and approve QMS documents such as change control and CAPA.
• Create and lead employee training programs on quality systems and GMP.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific field.
• Minimum 2 years of experience in pharmaceutical quality assurance.
• Strong knowledge of GMP, ICH, ISO, and ISPE guidelines.
• Proven experience in QMS implementation, internal auditing, and managing regulatory audits.
• Proficiency in quality management software and Microsoft Office Suite.
• Must be based in or able to work on-site in Middletown, DE

Nice to have

• Experience in a greenfield manufacturing site startup.
• Experience in OPEX and Lean Six Sigma concepts.
• Experience in OSD manufacturing processes and aseptic processing.
• Knowledge of risk management tools (e.g., FMEA).
• Knowledge of quality engineering and statistical process control concepts.

Culture & Benefits

• Competitive salary and comprehensive benefits package.
• Opportunities for professional growth in a collaborative environment.
• Exposure to innovative pharmaceutical manufacturing projects.