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**Shift** : 8:00 AM to 5:00 PM, Monday–Friday. Onsite at a third-party GMP-compliant warehouse in PA.

Job Description:

+ 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.

+ This role is physically active and requires passing an eye exam, lifting materials (~40 lbs), and consistent gowning (jumpsuit, scrubs, goggles).

+ Strong attention to detail, comfort in a warehouse environment, and GMP compliance experience are essential.

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 client’s 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 client’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.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"