Specialist Quality Control

Juncos, PR
Autónomo
Tiempo completo

Hace 6 días

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!Job DetailsSummary of Role:Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.Responsibilities:

Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
Resolve technical issues and troubleshoot for assays as necessary
Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
Manage existing and/or develop and implement new programs, processes and methodologies.
Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
Approve lab investigations, Lead audit teams
May serve as subject matter expert to develop technical training.
May perform routine work in a specific area of responsibility as necessary.
Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.
May interact with regulatory agencies regarding area(s) of responsibility including written responses.
May resolve issues with outside resources.
Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.

Shift: AdministrativeLocation: Juncos, PREducation: Preferable Scientific Background (Science or Engineering) with experience in Pharmaceutical Industry, Quality Control, Laboratory Testing, Project Management and Quality processes. Preferable experience as Microbiologist, Chemist, Biochemistry, Molecular Sciences, or Chemical Engineering.Preferred Qualifications:

Scientific Data Analysis
Strong Technical Writing (English and Spanish) mainly focuses
Strong knowledge in Microsoft Excel as a Tool for Data Analysis
Good Communication skills
Project Management
Knowledge in Computer System and Method Validation (Experience preferable)
Strong knowledge and experience with quality process management
Knowledge on equipment validation and troubleshooting (Experience preferable))
Agile on prioritization of critical tasks
Ability to develop inspection or qualification protocols in a short timeframe period.
Strong negotiation skills
Usage of KNEAT platform and Kaye validator (Experience Preferred)

Skills:

Understand, support and demonstrate the AMGEN values.
Excellent communication skills, facilitation and presentation skills.
Excellent technical writing skills.
Strong computer operation skills including work processing, presentation, database and spreadsheet application skills.
Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
Knowledge of pharmaceutical processes.
Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
Extensive knowledge and application of GMPs/CFRs.
Ability to evaluate compliance issues.
Skill in evaluating and documenting according to Company and various guidelines.
Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
Advanced scientific data analysis and interpretation skills.
Advanced skills in solving complex problems.
Advanced data trending and evaluation.
Strong skill in working independently and to effectively interact with various levels.
Ability to interact with regulatory agencies both orally and in writing.
Initiate, coordinate and lead cross functional teams.
Excellent skill in leading, motivating, influencing, and negotiating.

This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.What Cencora offersWe provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visitFull timeEqual Employment OpportunityCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returnedAffiliated Companies Affiliated Companies: Echo Consulting Group Inc

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