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Posted: Tuesday, April 25, 2017 10:23 PM

Job Description:/h3:
Company Overview
Sancilio and Company, Inc. (SCI) is a biopharmaceutical company focused on Advanced Lipid Technology(tm) (ALT) and complimentary products. Unlike most research stage companies, SCI has developed a portfolio of commercialized products that are developed, manufactured and distributed by our own dedicated people in our own cGMP manufacturing facilities.

Description
This position will be responsible for validation documentation activities in a cGMP regulated pharmaceutical manufacturing environment. The candidate will prepare validation documents to support new product launches and any changes to existing validated manufacturing processes for regulated products.


Duties and Responsibilities
:Develop validation master plans, protocols, process flow diagrams, test cases, and standard operating procedures.
:Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols and procedures.
:Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
:Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, and protocols.
:Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
:Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
:Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
:Identify deviations from established product or process standards and provide recommendations for resolving deviations.
:Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
:Other duties as assigned.


Knowledge, Skills and Abilities
:Working knowledge of FDA Regulations and Guidances as they pertain to validation.
:Demonstrated ability to work in both a multi:discipline team and independently.
:Ability to manage multiple projects.
:Proficient in MS Office applications.
:Excellent verbal and written communication skills.
:Fluent in English.

Interface
This position will interact with both internal and external customers

Security Requirements
The selected individual must be able to successfully pass a background and drug screening as a condition of employment. The selected individual must also meet eligibility and suitability requirements.


Physical Demands
The physical demands described here, typical to that of a manufacturing environment, are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand and use hands along with fingers, to handle or feel. The employee is regularly required to stand, walk, reach with hands and arms, climb or balance, and stoop, kneel, crouch or crawl. The employee may frequently lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision.


Work Environment
The work environment, typical to a manufacturing environment, characteristics described here are representative of those encountered while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Minimal travel is expected.


Work Environment
The work environment, typical to an office environment, characteristics described here are r

Source: https://www.tiptopjob.com/jobs/66277924_job.asp?source=backpage


• Location: West Palm Beach

• Post ID: 49320998 westpalmbeach
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