Cgmp Quality Assurance Specialist

Piper Companies is currently seeking a cGMP Quality Assurance Specialist for an opportunity in Everett, Pennsylvania (PA), to join a pioneering biotechnology company.

Responsibilities of the cGMP Quality Assurance Specialist

• Take a leadership role in quality decisions by supporting change control processes, CAPA systems, deviation processes, nonconforming material processes, customer complaints, supplier approvals, material receiving, internal audit processes and document control

• Conduct batch record review, root cause analysis, and establish corrective actions for non-conformances

• Review and approve incoming materials, assess deviations, and handle supplier approvals

• Participate in audits, SOP writing, and maintain procedural knowledge

Qualifications of the cGMP Quality Assurance Specialist

• 2+ years of experience within a quality role in an environment following ISO-9001 and ISO-13485 standards

• Experience with batch records, CAPAs, supplier approvals, internal audit processes, and document control

• Proficient in maintaining accurate records and skilled in Windows, Word, and Excel

• Bachelor's degree in quality/compliance or related science field is required

Compensation for the cGMP Quality Assurance Specialist

• Salary Range: $60,000 - $80,000
• Benefits: Medical, Dental, Vision, 401k match, Paid Holidays, and PTO

Keywords: QA, quality assurance, quality, compliance, cGMP, GMP, current good manufacturing practices, change controls, CAPA, corrective and preventative action, deviations, nonconformance, nonconforming material process, customer complaints, suppliers, supplier management, materials, materials receiving, internal audit, manufacturing, biotech, biotechnology, pharma, pharmaceutical, medical device, ISO-9001, ISO 9001, ISO 13485, quality management, QMS, quality management systems, regulatory, ISO, international organization for standardization, validation, incoming suppliers, doc control, SOPs, standard operating procedures

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