Qualty Control and Quality Assurance Jobs

Perform in-process, release, stability, and process validation testing of products.
• Maintain cGMP laboratory documentation.
• Develop and validate analytical methods.
• Perform site qualification testing.
• Write technical reports for method validations, site qualifications, memos and investigation reports.
• Calibrate, troubleshoot, and maintain laboratory instrumentation.
• Perform cleaning validation testing.
• Handling and disposal of hazardous and non-hazardous laboratory waste.
• Other duties may be assigned as necessary.

BASIC QUALIFICATIONS:
• Bachelor’s degree in Chemistry or other related science.
• Basic knowledge of Microsoft Windows, Word and Excel.

ADDITIONAL QUALIFICATIONS
• HPLC and GC experience preferred, but not required.
• Accuracy, thoroughness, attention to detail.
• Reliability, accuracy, and integrity required for cGMP and FDA compliance and to ensure product quality and prevent recalls.

Having reached a high level of technical expertise, works independently with QC staff to validate QC instrumentation. Reviews and approves documentation including specifications, standard operating procedures, protocols and reports. Provides independent QC input to projects in support of commercial or clinical manufacturing. Administers change control activities for QC laboratory instruments and leads annual re-qualifications. Provides direction to project teams on compliance/technical issues related to efforts to achieve compliance with company policies and government regulations. Independently troubleshoots problems and resolves issues regarding instrument validation.

Job Responsibilities

*Qualifies QC laboratory instrumentation and validates laboratory computerized systems.

*Performs system administration functions for laboratory benchtop computerized systems.

*Generates and reviews documentation for compliance with company policies and government regulations.

is position can be filled at an QC Associate or QC Scientist I level.

Performs chemical assays of production intermediate and bulk samples, finished product, process & cleaning validation samples, and package samples.Assays are qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, Wyeth standard operating procedures, and approved license requirements. Results are compared with specifications and documented. Incumbent has working knowledge of fundamental technical and quality concepts and receives minimal supervision on routine assignments.

Job Responsibilities

Develop, test, validate, document, maintain, and execute software and/or systems using the currently endorsed computing tools in support of clinical trials reporting activities. Create analysis and reporting data sets and generate output (listings, summary tables, and graphs) as detailed in the reporting specifications using SAS and other software. Maintain and verify the quality and accuracy of all output. Review data and outputs to assure accuracy and consistency. Assist in the integration of data into aggregated data sets. Keep management updated on all activities. Ability to identify and solve technical problems and to work independently on assigned tasks.

For Manager/C5 level;
-Posess project and matrix management skills in order to lead/facilitate a cross-functional group. Possess high-level cross functional and business knowledge.
-Posess ability to lead both project and non-project activities concurrently.
-Lead in Planning complex cross-functional projects.

Join us and experience our culture first-hand – one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Possesses unique combination of analytical/scientific skills as well as excellent managerial skills in order to effectively manage and control all activities necessary to support a Quality Operations program governing external manufacturers of API and API intermediates, in conjunction with and under the direction of the Quality Operations director. Receives guidance on policy issues and direction with regards to operations.

1. Assures that the Quality Operations department operates within established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, EPA, etc.), both domestic and foreign.

Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Merck's Elkton, VA facility known as Stonewall has an immediate need for a dynamic candidate for an Associate Analytical Chemist position in our Quality group. The Stonewall Plant is located in the Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains. The facility is just a short distance from major state universities: University of Virginia and James Madison University. The Stonewall Plant offers pharmaceutical manufacturing opportunities in the following areas: Organic Synthesis, Fermentation, Bulk Sterile Product Manufacturing, Vaccine Manufacturing, Pharmaceutical Formulation and Sterile Product Finishing.

Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Senior Automation Analyst will be a senior member of the West Point team to provide quality guidance and approval of computer system validation projects. Responsible for effective documentation review and conformance to Merck Manufacturing Standards, Merck Manufacturing Division Quality Policies, and cGMPs for the generation of Quality Assurance Plans, Requirements specifications, Design Specifications, and Test Protocols.

Job Summary:
Perform assigned batch record reviews and review of other records relating to processing of components, materials and finished veterinary biologicals for comparison with approved specifications and regulatory requirements. The position will cross train with production supervisory functions.

RESPONSIBILITIES
• Perform assigned batch record reviews and review of other records relating to the processing of components, materials and finished veterinary biologicals for comparison with approved specifications and regulatory requirements.
• Review and approve assigned new and revised documents (e.g., specifications, procedures, processes, methods, protocols and reports) associated with veterinary biological production and production support operations.
• Participate in the preparation for and execution of foreign and domestic regulatory agency inspections.

Performs chemical assays of commercial product raw materials. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, Wyeth standard operating procedures, and approved license requirements. Results are compared with specifications and documented. Incumbent has a basic knowledge of fundamental technical and quality concepts and receives daily supervision.

Job Responsibilities

Receives daily assignments to perform various analyses on raw materials for use in routine production. Reviews and verifies result accuracy. Learns to recognize atypical or out-of-specifications test results, instrument malfunctions and methodology problems and participates in the investigation to resolve and correct.

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Consistently cited as a great place to work, we discover, develop, manufacture and market a wide range of vaccines and medicines to address unmet medical needs. Each of our employees is joined by an extraordinary sense of purpose — bringing Merck's finest achievements to people around the world.

We offer an excellent salary and an industry-ranked benefits program, including tuition reimbursement, work-life balance initiatives and developmental programs at all levels. Merck's retirement package includes a pension plan and one of the best 401(k) plans in the nation.