Senior QA Associate/QA Lead, Compliance
4 weeks ago
The Senior QA Associate, Compliance/QA Lead will be responsible for identifying, closing, and implementing corrective actions regarding gaps in current good manufacturing practices (cGMP) related activities to comply with FDA regulations, support Serialization and aggregation process implementation for Granules Consumer Health. You will work closely under the guidance of Quality Assurance (QA) Manager, and interact with Operations, Warehouse, and Supply Chain professionals to drive compliance and right first-time practices in our operations at Manassas, VA.
Through direct participation and contribution towards improvement of site Compliance, you will develop hands on experience working in a Pharma Packaging site to help promote safety and quality of our products.
As a Senior QA Associate, Compliance/QA Lead, you would be responsible for ensuring product compliance to established cGMPs, to meet safety and quality standards for FDA Regulatory and customer requirements by adherence to Standard Operating Procedures (SOPs). Based on products and packaging activities the tasks assigned may vary in scope, sequence, complexity, and timing. Individuals will be trained and will have an opportunity to apply their knowledge of science and prior experience in cGMP operations to execute and deliver results through improvement in Compliance at the Manassas site.
Responsibilities include but not limited to:
- 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.
Minimum Experience & Education 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
- Hands on experience in implementation of Serialization and aggregation process highly preferred
- Knowledge of Good Manufacturing Practices (cGMP).
Required Knowledge/ Skills
- Proven knowledge of cGMP procedures and processes.
- Hands on experience in implementation of Serialization and aggregation process.
- Proficient in documentation as per Good Documentation Practice.
- Troubleshooting abilities.
- Computer skills including Microsoft and Excel.
- Excellent verbal and written communication skills
Physical Requirements/Working Environment
- Laboratory environment with lab coats and safety glasses.
- 8 hours per day.
- 6-8 hours standing while performing the task.
- Must be able to lift 50lbs.
-
Senior QA Associate/QA Lead, Compliance
2 weeks ago
Manassas, United States Granules Pharmaceuticals Full timeJob Type Full-time Description The Senior QA Associate, Compliance/QA Lead will be responsible for identifying, closing, and implementing corrective actions regarding gaps in current good manufacturing practices (cGMP) related activities to comply with FDA regulations, support Serialization and aggregation process implementation for Granules Consumer Health....
-
Senior QA Associate/QA Lead, Compliance
3 days ago
Manassas, United States Granules Pharmaceuticals Full timeJob Type Full-time Description The Senior QA Associate, Compliance/QA Lead will be responsible for identifying, closing, and implementing corrective actions regarding gaps in current good manufacturing practices (cGMP) related activities to comply with FDA regulations, support Serialization and aggregation process implementation for Granules Consumer Health....
-
Jr. QA Tester
4 weeks ago
Manassas, Virginia, United States IT Excel Full timeRELOCATION IS A MUST AND 4 WEEKS MANDATORY IN-PERSON TRAINING IN RESTON VATitle QA Analyst/ Jr. QA Tester/Business Analyst/BA/Jr. Validation EngineerQualificationsBS in Computer Science/ MS Computer Science/ BBA/ MBA/ BS in Biomedical Engineering/ BS in Chemical Engineering/ Engineering degree required from an accredited university or college.Minimum...
-
Electrical QA/QC Inspector
2 weeks ago
Manassas, United States AM Technical Solutions, Inc Full timeElectrical QA/Commissioning (Journeyman Electrician)Virginia Summary:We are looking for a qualified Electrical resource to support commissioning and quality responsibilities for a client of ours in the Virginia area. This individual will be primarily responsible as a primary point-of-contact regarding code compliance and constructability for Construction...
-
Electrical QA/QC Inspector
2 weeks ago
Manassas, United States AM Technical Solutions, Inc Full timeElectrical QA/Commissioning (Journeyman Electrician)Virginia Summary:We are looking for a qualified Electrical resource to support commissioning and quality responsibilities for a client of ours in the Virginia area. This individual will be primarily responsible as a primary point-of-contact regarding code compliance and constructability for Construction...
-
Senior Quality Specialist
4 weeks ago
Manassas, United States Notal Vision Full timeWe are looking for an experienced quality assurance specialist to join our QA global group.POSITION SUMMARY:Reporting to Notal Vision’s Manager, Quality Management, the Quality Associate assists management to maintain the Quality Management System (QMS) in compliance with applicable standards and regulatory requirements. The Quality Associate will lead the...
-
Senior Quality Specialist
4 weeks ago
Manassas, United States Notal Vision Full timeWe are looking for an experienced quality assurance specialist to join our QA global group.POSITION SUMMARY:Reporting to Notal Vision’s Manager, Quality Management, the Quality Associate assists management to maintain the Quality Management System (QMS) in compliance with applicable standards and regulatory requirements. The Quality Associate will lead the...
-
Senior C++ Developer
6 days ago
Manassas, United States GSSR Inc Full timeJob DescriptionJob DescriptionIn the first round of interview, the candidate will haveto do Coding.The candidate will have to goonsite for the Final round interview. Description:Code, test,review SWIFT software using technologies including C++, STL, Boost, Multithreading, Unix, Perl, Python and XML. Requirement analysis and Design of new features and...
-
Quarantine Specialist
2 weeks ago
Manassas, United States The Adecco Group Full timeAdecco is assisting a local company in recruiting for a current Quarantine Specialist opening in Manassas, VA. This is for a contract-to-hireopportunity. As a Quarantine Specialist, you will be responsible for auditing the products and processes at Specialist, QA Supervisor, Manufacturing, Staffing, Materials, Quality
-
Commercial Operations Assistant
4 weeks ago
Manassas, United States Granules Full timeJob DescriptionJob DescriptionDescription:Granules Consumer Health (GCH) is Granules’ front-end products division for private label over the counter (OTC) products in the US products. GCH was established in 2014, to offer OTC generics that meet the highest level of quality at an affordable cost that is much more affordable than brand name product. As a...
-
Senior Project Manager Govt Contracts
2 days ago
Manassas, United States The Roberts Company Full timeJob Title: Senior Project Manager - Government Contracts Job Description: Our client is seeking an experienced Senior Project Manager with a minimum of 10 years of project management expertise, particularly in leading projects that have advanced to a program of record. The ideal candidate will possess a PMP Certification and demonstrate a comprehensive...
-
Lead Associate Operations
2 weeks ago
Manassas, United States JPMorgan Chase & Co. Full timeWe have an obsession for taking care of our customers and employees and making them feel welcomed and valued through building lasting relationships, doing the right thing, exceeding expectations, and having a strong commitment to diversity and inclus Operations, Associate, Lead, Customer Experience, Operation, County, Manufacturing
-
Senior Project Manager
4 weeks ago
Manassas, United States The Roberts Company Full timeJob DescriptionJob DescriptionJob Title: Senior Project Manager - Government ContractsJob Description:Our client is seeking an experienced Senior Project Manager with a minimum of 10 years of project management expertise, particularly in leading projects that have advanced to a program of record. The ideal candidate will possess a PMP Certification and...
-
Technology Platform Transformation Lead
1 week ago
Manassas, United States Swift Full timeAbout the RoleWe're the world's leading provider of secure financial messaging services. We are the way the world moves value - across borders, through cities and overseas. No other organisation can address the scale, precision, pace and trust that this demands, and we're proud to support the global economy.We're unique too. We were established to find a...
-
Senior Principal Subcontract Admin
4 weeks ago
Manassas, Virginia, United States BAE Systems Full timeJob Description Hybrid: Because this role involves a combination of collaborative/in-person and independent work, it will take the form of a hybrid work format, with time split between working onsite and remotely.An exciting opportunity for a Senior Principal Subcontract Administrator to engage and support a variety of programs within the C4ISRS Business...
-
Senior Software Engineer
2 days ago
Manassas, United States MCL Systems Limited Full timeSenior Software Engineer Job Purpose A senior software engineer to play a role of software architect, project lead, andsoftware developerfor a software product company. Background Our company, MCL Systems Limited (MCL), is a developer of state of art telecom Billing and OSS software solutions, CadebillandGanges. These solutions are used by...
-
Senior Software Engineer
12 hours ago
Manassas, United States MCL Systems Limited Full timeSenior Software Engineer Job Purpose A senior software engineer to play a role of software architect, project lead, andsoftware developerfor a software product company. Background Our company, MCL Systems Limited (MCL), is a developer of state of art telecom Billing and OSS software solutions, CadebillandGanges. These solutions are used by telecommunication...
-
Sales Associate
2 weeks ago
Manassas, United States Modern Remodeling, Inc. Full timeJob DescriptionJob DescriptionBenefits:Competitive salaryDental insuranceHealth insuranceTraining & developmentVision insurance Modern Remodeling is an industry leading insurance restoration contractor with over 30 years in business. We are seeking focused, energetic, and driven Exterior Sales Associates to join our Storm Restoration team. Sales Associates...
-
Estimator
2 weeks ago
Manassas, United States CARSTAR Manassas Collision Center Full timeJob DescriptionJob DescriptionJOB SUMMARY & QUALITIES The Appraiser is responsible for providing customers with timely and friendly appraisals, with the ultimate goal of closing the sale to maintain a high closing ratio. The appraiser must handle communication with the adjuster and customer regarding status of the vehicle. This position is often the main...
-
Senior Quality Engineer
1 week ago
Manassas, United States Aurora Life Sciences Inc Full timeThe Company Our client is a leading medical device manufacturer with a strong reputation for being best in class. You will be joining an innovative team that have created a life changing product in the market. If you are a passionate, driven and dedicated Quality Engineer who has a passion for bringing safe medical devices to market this would be a great...