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24 days old

MANUFACTURING DOCUMENTATION SPECIALIST

Kelly Services
Manatí, PR 00674
**MANUFACTURING DOCUMENTATION SPECIALIST**


MAJOR DUTIES AND RESPONSIBILITIES:

Perform review of 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).

Perform batch record review for the manufacturing different stages in order to ensure compliance with established procedures and documentation requirements, as well as cGMP regulations.

Audit and approve the executed batch records of manufacturing processes 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.

Alert 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

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.

Categorize and reports documentation errors and deviations in order to aware management of trends and focus on the required corrective measure. Support investigations providing supplemented information related to Sterile Operations events.


REQUIREMENTS:

B.S. in Natural Science (Chemistry, Microbiology, Biology) or related fields.

At least 1-2 years of experience in a regulated environment. Manufacturing or Quality experience, preferable in a documentation function.

Computer literate (knowledge on Microsoft Word, Microsoft Excel, Microsoft Power Point, QC-Main and SAP).

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.

Knowledge of compendia requirement and cGMP, FDA regulations and the ability to interpret and apply them.

Must possess good verbal and written communication skills in English and Spanish

Capable to manage multiple priorities.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-03-26 Expires: 2021-04-26

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MANUFACTURING DOCUMENTATION SPECIALIST

Kelly Services
Manatí, PR 00674

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