Specialist Quality Assurance

Pay range: 25-35/hr

• depending on exp The ideal candidate will have 5+ years of QA experience
• specifically involving raw materials
• in a GMP-regulated environment such as pharmaceutical, biotech, or other life sciences industries.

A bachelors degree is strongly preferred; masters candidates may be considered, but Ph.D.-level talent may be too senior for the scope. This role is physically active and requires passing an eye exam, lifting materials (~40 lbs), and consistent gowning (jumpsuit, scrubs, goggles). While officially remote (per internal classification), the worker must be onsite daily. Candidates must be local or self-relocate, no exceptions. Strong attention to detail, comfort in a warehouse environment, and GMP compliance experience are essential. Avoid candidates seeking remote-only work or lacking QA/GMP/raw material background.

Responsibilities:

• Ensure that all operations comply with relevant regulations and requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices
• Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition
• Compile and review documentation associated with receipt, storage, incoming inspection, and distribution
• Perform routine Quality Assurance assessments and provide direct operational oversight
• Provide expert advice on quality matters to operational teams and cross-functional groups
• Ensure staff complete necessary training related to business operations
• Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required
• Achieve established metric targets and develop standardized approaches for tracking progress
• Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement
• Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies
• Support internal and external audits and inspections as a member of the audit/inspection team
• Perform additional duties as assigned by management

Preferred Qualifications:

• Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing
• Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
• Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions
• Expertise in managing deviations, change controls, and CAPAs
• Proficiency in Veeva, SM LIMS, and ERP systems
• Knowledge of industry standards (GMP, GDP, Import/Export)
• Commitment to exemplifying core values
• Demonstrated self-leadership and motivation
• Strong strategic thinking skills
• Ability to evaluate compliance issues and engage with regulatory inspectors
• Experience managing multiple priorities within a dynamic environment
• Direct experience with drug substances and/or drug products
• Advanced problem-solving abilities and capacity for scientific, risk-based decision-making
• Track record of representing an organization during regulatory interactions
• High proficiency in Microsoft Excel, Word, and PowerPoint