Quality Assurance Specialist

Payrate: $30.00 - $33.00/hr.


Summary:
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 bachelor's degree is strongly preferred; master's 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 Company's 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

Top 3 Must Have Skill Sets:

• Warehousing
• Raw material incoming inspection and sampling
• Raw material disposition

Pay Transparency: The typical base pay for this role across the U.S. is: $30.00 - $33.00 /hr . Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.


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