Summary 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: Administrative

Location: Juncos PR

Education: 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
• Basic Knowledge on equipment preventive maintenance and troubleshooting
• Agile on prioritization of critical tasks
• Ability to develop inspection or qualification protocols in a short timeframe period.
• Strong negotiation skills

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 (dba PharmaLex a Cencora company) partners on site at their facility.

What Cencora offers

We 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 visit time

Equal Employment Opportunity

Cencora 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 companys 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 returned

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