| 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 Associate, with guidance from the Release Analyst or Senior Release Coordinator, ensures product quality and performs activities to facilitate release of product to the marketplace and ensures proper control of material through maintenance of the quarantine system. The Associate performs 100% process document audit for accuracy and completeness and works closely with various departments in a team environment to ensure timely release to the marketplace.
The Release Associate will become knowledgeable in Federal and other regulatory agency requirements and GMPs to assure that all areas in compliance, and will train on and gain competency in activities to facilitate release of product for assigned products. Specific responsibilities include but are not limited to the following:
- Performs 100% audit of process documents to ensure completeness and accuracy for assigned products. Maintains departmental tracking databases and logs associated with document review.
- Ensures proper identification of release status and control of product through maintenance of quarantines in the IMPACT system and through physical tagging of material as required.
- Works with Manufacturing and GVTE (Global Vaccines Technology & Engineering) personnel to resolve outstanding quarantine issues.
- Performs IMPACT transactions required to document Batch Record review.
- Coordinates with Manufacturing to discuss, resolve and eliminate documentation observations.
- Prioritizes review of process documents in order to maximize cycle-time efficiency.
- Reviews Emergency Stamps / hand Stamps entered into OPG and batch record.
- Performs Quality review of new and updated Site Master Formulas.
- Audits Sterilization Logs in production.
Please note, we are unable to provide relocation assistance for this position. Qualifications
Required:
- B.S. degree with a technical emphasis in an appropriate scientific or engineering field.
- At least one year of relevant post-degree work experience in a laboratory, manufacturing, or quality position.
- Evidence of leadership skills coupled with good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
- Attention to detail, flexibility and an awareness of production and attendant quality control problems.
Preferred:
- Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior batch record experience is a strong plus.
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 # REL000124. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations. Search Firm Representatives
Please Read Carefully:
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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