What are the responsibilities and job description for the Specialist Quality Assurance position at Genesis10?
Pre ID
Description
ONSITE AT: Easton, Pennsylvania reporting daily. The candidate will physically work on-site at Langham Logistics, a third-party GMP-compliant warehouse in Pennsylvania.
Expected hours: 8:00 AM to 5:00 PM, MondayFriday.
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 ***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
Genesis10 is an Equal Opportunity Employer/Minorities/Female/Disabled/Veteran
Description
ONSITE AT: Easton, Pennsylvania reporting daily. The candidate will physically work on-site at Langham Logistics, a third-party GMP-compliant warehouse in Pennsylvania.
Expected hours: 8:00 AM to 5:00 PM, MondayFriday.
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 ***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
Genesis10 is an Equal Opportunity Employer/Minorities/Female/Disabled/Veteran