Kelly Services Aseptic Process Support Specialist in Manati, Puerto Rico
Originates and implements Microbiology Laboratory change controls following Site 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 Site 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, 5’s, 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. SOP’s, 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.
Reviews new product specification ensuring the generated data at site level, comply with the proposed specifications.
Conducts internal audits in the Microbiology Lab to ensure that the areas are in compliance with Site procedures and policies.
Supports the generation of protocols, reports, technical assessments and technical memos.
• 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 ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.