Specialist Quality Control

Weil Group, Inc; Juncos (PR); On-site; USD 110,000 - 150,000; Full time

Job summary

Weil Group, Inc. is seeking a technical specialist in testing and development with a strong background in molecular biology and microbiology. The role focuses on resolving complex technical issues across multiple sites and coordinating with outside resources.

The candidate will ensure GMP/GLP compliance, develop new programs, and lead cross-functional teams while maintaining high standards of data analysis and technical writing. Experience with regulatory interactions is a plus.

Qualifications

• PhD or equivalent with extensive molecular biology & microbiology background.
• Experience with GMP/GLP compliance and safety procedures.
• Ability to develop, revise and audit complex controlled documents.
• Strong data analysis and technical writing skills.
• Experience leading cross-functional teams and audits.
• Ability to interact with regulatory agencies in writing and orally.

Responsibilities

• Provide technical guidance and reports, ensure flow of communication between teams.
• Troubleshoot assays and resolve technical issues.
• Ensure GMP/GLP compliance and safety in the lab.
• Develop and implement new programs, processes and methodologies.
• Lead audits and approve lab investigations.

Skills

Communication skills

Data analysis

Technical writing

Project management

Independent work

Regulatory interaction

Cross-functional leadership

Education

Doctorate

Masters + 2 years experience

Bachelors + 4 years experience

Associates + 8 years experience

High school/GED + 10 years experience

Job description

SUMMARY

Under general direction, functions as the technical specialist for testing & 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.

FUNCTIONS

• 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.

EDUCATION

• Doctorate OR
• Masters + 2 years of directly related experience
• Bachelors + 4 years of directly related experience
• Associates + 8 years of directly related experience
• High school/GED + 10 years of directly related experience

COMPETENCIES/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.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*