Quality Compliance Specialist

Carolina, Puerto Rico
Contracted
Technical Services
Experienced
We are seeking a Quality Compliance Specialist with strong expertise in GMP regulations and proven experience in Oral Solid Dosage (OSD) operations. The ideal candidate will contribute to ensuring compliance, supporting qualification strategies, and applying best practices in facility and process design aligned with industry standards.

Key Responsibilities:
  • 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.

Requirements:
  • 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.

Preferred Qualifications:
  • Experience with design and startup of OSD manufacturing areas.
  • Certification in Lean, Six Sigma, or Quality Assurance.
  • Experience interacting with regulatory agencies.
Candidate should be able to commute to site since relocation is not available. 

"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.

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