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Batch Record Reviewer

Employer
Bristol Myers Squibb Company
Location
Manati, PR, United States
Start date
Nov 5, 2019

Job Details

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

This position is responsible for the on line /off line review and approval, from DPO standpoint, of manufacturing batch records associated to all manufacturing process. Review and approval of process related documentation such as Log Books, Cleaning Forms within others and overlook manufacturing activities to assure that are carried out within the framework of corporate/governmental policies and regulations (cGMP's). The incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices, required by the job function.

Major Duties and Responsibilities:

1. Reviews procedures, batch record and/or forms to assure update with current practice, audits or cGMP and to address requirements of corrective and prevention actions (CAPAs).
2. Performs batch record reviews for the manufacturing different stages in order to ensure compliance with established procedures and documentation requirements, as well as cGMP regulations.
3. Audits the executes batch record for all products manufactured at the site. This involves but not limited to the review of product and components reconciliation, completeness and correctness of information, in-process testing, sampling, expiration date, operation sequence and repeatability of the process.
4. Alerts management on trends noted on evaluated process and verify actions taken in order to restate control and

participate on the prevention and identification of root causes and internal complaints to pursue permanent corrective measure
5. Evaluate reports and documents the nature of incident and/or deviations at the time of occurrence of during document verification in order to determine immediate corrective actions to be taken and follow up on the investigation cause corrective/ preventive actions and documentation requirements.
6. Categorize and reports documentation errors and deviations in order to aware management of trends and focus on the required corrective measure.
7. Support investigations providing supplemented information related to Sterile Operations events.

This is intended to be a general job description and should not be construed as all inclusive.

Knowledge:

1. B.S. in Natural Science (Chemistry, Microbiology, Biology) or related fields.
2. At least 1-2 years of experience in a regulated environment. Manufacturing or Quality experience, preferable in a documentation function.
3. Computer literate (knowledge on Microsoft Word, Microsoft Excel, Microsoft Power Point, QC-Main and SAP).
4. Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action. Must be able to correlate events and determine the action plan required to avoid incidents recurrence and apply them.
5. Knowledge of compendia requirement and cGMP, FDA regulations and the ability to interpret and apply them.
6. Must possess good verbal and written communication skills in English and Spanish
7. Capable to manage multiple priorities.

Skills:

1. Attention to details.
2. Ability to detect discrepancies, detect trends.
3. Skilled in DCA, Trackwise systems, among others.
4. Good analytical and mathematical skills.
5. Ability to create high quality reports with minimum inputs.
6. Customer Service oriented.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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