Job Details

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