Quality Compliance Specialist

• Ensure compliance with current Good Manufacturing Practices (cGMP) in all quality systems and manufacturing operations.
• Support and/or lead qualification strategies for equipment, utilities, and facilities related to OSD.
• Participate in cross-functional teams during the design and construction of new or modified OSD facilities.
• Provide quality oversight for manufacturing, validation, cleaning, and packaging of oral solid dosage forms.
• Review and approve documentation such as SOPs, protocols, deviations, and CAPAs.
• Conduct risk assessments and gap analyses to drive continuous improvement.
• Collaborate with Engineering and Validation teams to ensure best practices are applied in OSD facility design.

• Bachelor’s degree in Pharmacy, Chemistry, Engineering, or Life Sciences.
• 5+ years of experience in a Quality role within the Pharmaceutical industry, with strong focus on OSD manufacturing.
• In-depth knowledge of FDA and international GMP regulations.
• Experience in qualification/validation strategies (IQ/OQ/PQ).
• Familiarity with ISPE, ASTM, and ICH guidelines.
• Strong analytical, communication, and problem-solving skills.
• Bilingual preferred: English & Spanish.

• Experience with design and startup of OSD manufacturing areas.
• Certification in Lean, Six Sigma, or Quality Assurance.
• Experience interacting with regulatory agencies.

"Drug Free Workplace Policy: In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment."

Share Tech Group is committed to being an equal opportunity employer, fostering a diverse and inclusive workplace where all individuals are treated with respect and provided with equal opportunities for employment and advancement.