Apply on Employer Site

Aditi Consulting · 7 hours ago

Quality Assurance Senior Associate

Holly Springs, NC

Contract

Onsite

Mid, Senior Level

$29/hr - $30/hr

Aditi Consulting is seeking a Quality Assurance Senior Associate to work closely with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introduction. The role involves ensuring adherence to GMP quality requirements and providing guidance and oversight during manufacturing processes.

AppsConsultingInformation TechnologySoftware Engineering

Growth Opportunities

H1B Sponsor Likely

Responsibilities

Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations

Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls

Drive closure/completion (including review and approval) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s

Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements

Oversee and provide guidance during on-the-floor analytical testing

Ensure that changes that could potentially impact product quality are assessed according to procedures

Ensure that deviations from established procedures are investigated and documented by procedures

Alert senior management of quality, compliance, supply and safety risks

Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation

Identification and implementation of continuous improvement opportunities within our processes and systems

Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections

Qualification

CGMP complianceQuality oversightBatch records managementPQA experienceB.S. degreeContinuous improvementAnalytical testingProject management

Required

Previous work on GNP Facilities

PQA or Mfg preferably Drug Substance Experience

Previous work with Batch records/Deviations/Qa Oversight

B.S. degree

Benefits

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

Discretionary performance or recognition bonus

Sick leave and mobile phone reimbursement provided based on state or local law.

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

Represents job field similar to this job

Trends of Total Sponsorships

2025 (55)

2024 (44)

2023 (25)

2022 (26)

2021 (24)

2020 (30)