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Aditi Consulting · 2 days ago

Specialist Quality Assurance

Easton, PA

Contract

Onsite

Senior Level

$30/hr - $32/hr

5+ years exp

Aditi Consulting is seeking a Specialist Quality Assurance with experience in QA specifically involving raw materials in a GMP-regulated environment. The role involves ensuring compliance with regulations, conducting inspections, and providing operational oversight in a physically active setting.

AppsConsultingInformation TechnologySoftware Engineering

Growth Opportunities

H1B Sponsor Likely

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

Qualification

QA experience in GMPGMP compliance experienceVeeva proficiencySM LIMS proficiencyERP systems proficiencyLife Sciences backgroundAttention to detailProblem-solving abilitiesSelf-leadershipDrug substancesComfort in warehouse environmentManage prioritiesRegulatory interaction experienceHigh proficiency in Microsoft OfficeStrategic thinkingEffective communication

Required

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

Passing an eye exam

Lifting materials (~40 lbs)

Consistent gowning (jumpsuit, scrubs, goggles)

Strong attention to detail

Comfort in a warehouse environment

GMP compliance experience

Preferred

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, changing 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

Benefits

Medical

Dental

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

Discretionary performance or recognition bonus

Sick leave

Mobile phone reimbursement

Company

Aditi Consulting

Glassdoor4.2

Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.

Founded in 1994

Bellevue, Washington, USA

1001-5000 employees

https://aditiconsulting.com

H1B Sponsorship

Aditi Consulting has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (55)

2024 (44)

2023 (25)

2022 (26)

2021 (24)

2020 (30)