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24 days old

Aseptic Process Support Specialist

Kelly Services
Manatí, PR 00674
**Aseptic Process Support Specialist**


Originates and implements Microbiology Laboratory change controls following procedures and policies ensuring the accuracy of the information and closing with established time frame.

Originates and implements corrective and preventive actions following procedures and policies and closing them within the established time frame.

Supports the Media Fill activities in order to assure that typical and atypical interventions are performed as established and that new ones are evaluated and integrated as required.

Supports smoke profiles tests.

Helps to ensure the aseptic techniques, cleaning and sanitization validations for clean rooms and isolators, HEPA Filter and Gowning process are adequate and effective.

Participates in the Environmental Review Committee covering also the utilities.

Interfaces directly with manufacturing operations to ensure that appropriate environmental and aseptic procedures are in place, through the execution of thorough reviews of procedures against practice.

Supports the clean rooms classifications qualifications and re-qualifications.

Assures that the manufacturing operations (Parenteral and / or Oral Solid Dosage) are performed in compliance with domestic and international cGMP regulations, and policies and procedures

Supports aseptic processing special projects to accomplish company goals and objective on a timely and effective manner.

Participates in the critical review of all documents associated with the manufacturing aseptic processing.

Support media fill APQR.

Provides formal presentations to upper management on environmental monitoring trends and aseptic processing status and opportunities, as applicable.

Supports different Operational Excellence initiatives in the Microbiology Laboratory such as visual aids, 5s, spaghetti diagram, standardize work, etc.

Supports complex Microbiology laboratory Investigations ensuring the identification of the root cause and the corrective end preventive action to prevent re-occurrence.

Recommends and make changes to documents (e.g. SOPs, protocols, Testing Standards, methods, monographs, etc.) and ensures consistency with other sites procedures and/or specifications.

Reviews new drug product filings to ensure are in accordance with current practices in the Microbiology lab and regulatory requirements.

Supports the generation of protocols, reports, technical assessments and technical memos.




Requirements:


Bachelor Degree in Natural Sciences or Engineering.


Minimum five (5) years of experience in Microbiology lab with at least two (2) years experience with the Aseptic Processing field.

Broad knowledge of cGMP governmental regulations and guidelines, and the ability to interpret and apply them

Ability to communicate effectively with wide range of personnel, written and verbal.

Strong technical writing and interpretation skills related to investigations and Regulatory Filings.

Extensive knowledge with the use and interpretation of pharmacopeias such as USP/NF, EP, JP, British.

Ability to create /organize cGMP systems and procedures based on regulatory compliance skills.

Experience with microbiology techniques such as isolator technology and aseptic processing techniques.

Knowledge and experience of computer and appropriate software packages (e.g., word processing, spreadsheets, communications like e-mail, LIMS, etc.).

Knowledge to collect and document data and /or other information (e.g. significant figures, rounding off rules, etc.).

Knowledge of computers applications (Microsoft Word, Excel, Power Point).

Excellent interpersonal skills and teamwork oriented.

Excellent communications skills in Spanish/English.

Knowledge of statistical tools.


**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)

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Posted: 2021-03-26 Expires: 2021-04-26

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Aseptic Process Support Specialist

Kelly Services
Manatí, PR 00674

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