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Aditi Consulting · 1 day ago

Quality Systems Specialist

Manassas, VA

Contract

Onsite

Entry, Mid Level

$24/hr - $24/hr

2+ years exp

Aditi Consulting is a company focused on quality systems and compliance, and they are seeking a Quality Systems Specialist. This role involves leading the resolution of quality issues, supporting audits and training, and improving quality documentation and processes.

AppsConsultingInformation TechnologySoftware Engineering

Growth Opportunities

H1B Sponsor Likely

Responsibilities

Assist in leading and coordinating the resolution and completion of Deviations, CAPAs, and batch record backlogs, collaborating with functional teams or assignees to drive timely completion

Partner with cross-functional teams to propose and implement process improvements for better visibility, accountability, and sustainability of quality systems, with the goal of avoiding future backlogs

Support the management and tracking of Deviations, CAPAs, Batch Records, Change Controls, and related quality records to ensure timely follow-up and effectiveness

Support preparation for internal and external audits and inspections and 24/7 inspection readiness

Coordinate training activities, ensuring personnel are trained on relevant SOPs, policies, and quality procedures

Assist in building a culture of quality awareness, accountability, and adherence to procedures across functions

Assist in establishing process to maintain accurate training records and escalate gaps to management

Assist in updating raw material specifications, including contacting vendors, gathering data, and revising controlled documents

Develop job aids, work instructions, and flowcharts to supplement SOPs, making procedures easier to understand and execute consistently

Ensure good documentation practices (GDP) are followed across the site

Support authoring, reviewing, and updating SOPs to reflect current cGMP requirements and company policies

Maintain organized, accessible records for traceability and compliance and remove superseded or draft versions of documentation

Partner with warehouse staff to promote organization, labeling, and adherence to inventory procedures

Assist in improving structure and documentation for materials/QA chemical inventories

Support visibility of material disposition, including traceability of materials and products placed on hold

Coordinate and track testing performed by contract laboratories, ensuring results are received, reviewed, and documented in a timely manner

Maintain visibility of raw material and product testing status, escalating delays or issues as needed

Develop and maintain trackers, logs, and dashboards in Microsoft Excel/Word/PowerPoint for quality system metrics and reporting

Support cross-functional communication to ensure timely follow-up on quality-related tasks and commitments

Provide general coordination support to the site Quality Team in daily operations

Qualification

Quality systems knowledgeGMP experienceSOP managementMicrosoft Office proficiencyPower BIOrganizationAccountabilityCommunication

Required

Bachelor's degree in a scientific or technical discipline preferred (e.g., Chemistry, Biology, Quality, Engineering). Equivalent experience considered

2-5 years of experience in a GMP-regulated manufacturing or consumer health/OTC environment

Strong knowledge of quality systems (Deviations, CAPA, Change Control, Training, Documentation, Batch Records)

Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook); ability to create reports, trackers, and presentations

Demonstrated ability to bring structure and accountability in environments requiring process discipline

Preferred

Experience supporting raw material specifications, SOP management, and training materials development

Power BI skill is preferred

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)