| Description
Meet the new Merck. A stronger pipeline. More products to help people in more ways. More passionate than ever about what matters to our customers.
Merck and Schering-Plough are now one company. We recently merged to create a stronger, more diverse and more truly global company. This not only benefits our company and our shareholders, but it also benefits the millions of people around the world who rely on our products and expect us to continue to deliver exceptional value.
The Release Coordinator, with guidance from the Product Release Manager or Senior Release Coordinator, ensures product quality and performs activities to facilitate release of Merck's pharmaceutical, vaccine and biologics products to the marketplace.
In this position, you will evaluate all relevant information related to a product lot to determine readiness for product release. The incumbent assures all required release documentation is approved, valid and complies with all Regulatory and Merck Manufacturing Division (MMD) requirements, and works closely with various departments in a team environment to ensure timely release to the marketplace. Primary activities include, but are not limited to:
- Product release activities:
- Preparing and reviewing batch release documentation such as CBER protocols, Certificates of Analysis, Can Trees, etc.
- Preparing Release Evaluation and Documentation System forms
- Scheduling and preparing paperwork for sample shipment
- Approving test data in LIMS and performs and approves trending of test data
- Working with Manufacturing and Technology and/or IPT personnel to resolve outstanding quarantine issues
- Performing IMPACT transactions required for the release of product and maintains quality master screens for assigned products
- Completing Pack IDs on packaged material per approved departmental procedure
- Reviewing and approving Priority/Risk Processing and controls material as appropriate
- Reviewing and maintaining LOTS schedules for assigned materials/products and coordinating activities with Manufacturing, Planning, IPT, Quality COE staff as appropriate to ensure release of all materials/product lots within established customer due dates
- Participating in routine planning meetings and communicating release issues and status to the team
- Executing Release Auditor/Associate duties as required (including, but not limited to: document review, quarantine management, tagging, reviewing and approving Site Master Formula revisions, etc.)
- Writing and reviewing Standard Operating Procedures and department Control Procedures.
- Carrying out defined projects targeted to improve and/or develop systems for product evaluation, performance and control, and completing projects independently with occasional direction and guidance as necessary.
- Administering quality standards and change controls for the laboratory procedures, worksheets, and related systems including management of scheduled and unscheduled reviews. Works with appropriate technical support groups to assure proper validation, development, and incorporation of specifications. Coordinates maintenance of LIMS templates to ensure compliance with Quality Standards.
- Working with and/or mentoring exempt, non-exempt and hourly employees. Provides training to incoming personnel and ensures compliance with departmental procedures.
- Supporting regulatory, divisional, and site inspection/audit requests.
- Performing technical close-out for Change Request for assigned products.
- Collaborating with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
Please note, relocation assistance is not provided for this position. Qualifications
Education
- A Bachelor's degree is required, preferably in an appropriate scientific or engineering field.
- Candidates with major fields of study in other areas may be considered if they possess additional relevant experience.
Required
- At least three (3) years of relevant post-degree work experience in a manufacturing or research environment or a related field.
- Strong analytical, problem solving, oral and written communication skills, leadership, and attention to detail.
- Solid understanding of regulatory requirements and GMPs.
Preferred
- Aseptic gowning may be required.
- Tites may be required.
- Vaccine or pharmaceutical manufacturing experience.
- Quality control and/or quality assurance audit/inspection experience.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
To be considered for this position, please visit our career site at www.merck.com/careers to create a profile and submit your resume for requisition # REL000134. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives
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Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
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