Senior QA Associate/QA Lead, Compliance (OSD Pharma Experience Required) jobs in United States
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Granules Pharmaceuticals, Inc. · 3 months ago

Senior QA Associate/QA Lead, Compliance (OSD Pharma Experience Required)

positionManassas, VA
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

Granules Pharmaceuticals, Inc. is seeking a Senior QA Associate/QA Lead to ensure compliance with FDA regulations and support Serialization and aggregation processes in their Pharma Packaging site. The role involves assessing compliance gaps, implementing corrective actions, and driving quality and safety standards in operations.

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H1B Sponsor Likelynote

Responsibilities

Conduct assessment of cGMP Compliance gaps
Support Serialization and aggregation process implementation as per the Drug Supply Chain Security Act (DSCSA)
Implement plans for gap closure and follow up on the corrective actions to ensure sustainable cGMP Compliance
Interpret, discuss and trends in key Quality metrics data to recommend changes required to sustain Quality and safety of manufactured products
Review and release of the batches
Participation in qualification of utilities, systems, and equipment on-site
Support training programs to ensure competency of personnel engaged in cGMP activities
Support all aspects of investigations, including out-of-specification and manufacturing investigations
Perform routine trouble shooting of cGMP excursions including determination of root cause analysis
Assist other analyses of data, and interpretation
Maintain and update key Quality metrics for assessment of cGMP at the Manassas site
Identify and communicate continuous improvement opportunities to the Quality Assurance Manager
Responsible for the safe and efficient execution of job duties and abiding by established quality standards
Exposure to enhance skills to develop a better understanding of applying and interpreting FDA regulations to medicinal drug products
Improve the site compliance through implementation of corrective actions to close identified cGMP gaps

Qualification

CGMP complianceOSD pharmaceutical packagingSerializationAggregationDocumentation PracticeTroubleshooting abilitiesMicrosoft OfficeVerbal communicationWritten communication

Required

Bachelors/master's in chemistry or related scientific field
Minimum 5+ years hands on Quality Assurance experience in Pharmaceutical Industry
Experience in OSD Pharmaceutical Packaging Operations required
Knowledge of Good Manufacturing Practices (cGMP)
Proven knowledge of cGMP procedures and processes
Proficient in documentation as per Good Documentation Practice
Troubleshooting abilities
Computer skills including Microsoft and Excel
Excellent verbal and written communication skills

Preferred

Hands on experience in implementation of Serialization and aggregation process highly preferred
Hands on experience in implementation of Serialization and aggregation process

Company

Granules Pharmaceuticals, Inc.

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Granules Pharmaceuticals, Inc. is a pharmaceuticals company based out of 3701 CONCORDE PKY, Chantilly, Virginia, United States.
dateFounded in 2014
location
Chantilly, Virginia, US
people-size51-200 employees

H1B Sponsorship

Granules Pharmaceuticals, Inc. 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 (49)
2024 (7)
2023 (22)
2022 (24)
2021 (10)
2020 (19)

Funding

Current Stage
Growth Stage

Leadership Team

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Gregory B. Reeves
Chief Human Resources Officer
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Company data provided by crunchbase