Quality Control Specialist (3500032)

ProQuality Network; United States; Hybride; USD 41 000 - 83 000; Plein temps

Résumé du poste

ProQuality Network seeks a Quality Control Specialist to provide technical guidance in molecular biology and microbiology testing. The role handles complex issues with multi-site impact and interacts with external resources as needed.

Responsibilities include data analysis, report generation, and ensuring GMP/GLP compliance while developing and auditing documents and leading cross-functional teams. This is a contract, onsite position for approximately six months.

Qualifications

• Doctorate or Master’s + 2 years of directly related experience required.
• Bachelor’s degree + 4 years of directly related experience required.
• Associate’s degree + 8 years of directly related experience required.

Responsabilités

• Provide technical guidance, generate reports, perform data analysis, and ensure cross-functional communication.
• Troubleshoot and resolve assay-related technical issues.
• Ensure laboratory compliance by implementing GMP/GLP and safety standards.
• Manage existing programs or develop new programs, processes, and methodologies.
• Develop, revise, and audit complex documents with multi-site impact.
• Approve laboratory investigations and lead audit teams.
• Serve as SME in development of technical training.
• Represent the department on cross-functional teams and manage multi-site action items.

Connaissances

Data analysis

Technical writing

Project management

Quality process management

GMP/GLP knowledge

Regulatory understanding

Cross-functional collaboration

Prioritization under dynamic env

Analytical problem solving

Inspection protocol development

Formation

Doctorate or Master’s +2 years related experience

Bachelor’s degree +4 years related experience

Master’s degree +2 years related experience

Associate’s degree +8 years related experience

High School/GED +10 years related experience

Outils

Microsoft Excel

Description du poste

Title: Quality Control Specialist (3500032)

Position: 1

Duration: Approximately 6 months

Work Model: 100% Onsite | Administrative Shift

Contract: This opportunity is by contract with ProQuality Network in representation of our client.

SUMMARY

Under general direction, the Quality Control Specialist functions as a technical expert in molecular biology and microbiology testing and development. This role addresses complex technical matters with multi-organizational and/or multi-site impact, including interactions with external resources as needed.

PREFERRED QUALIFICATIONS

• Scientific data analysis


• Strong technical writing skills (English and Spanish)


• Advanced proficiency in Microsoft Excel for data analysis


• Project management capabilities


• Knowledge of computer systems and method validation (experience preferred)


• Strong understanding of quality process management


• Basic knowledge of equipment preventive maintenance and troubleshooting


• Ability to prioritize critical tasks in a dynamic environment


• Ability to develop inspection or qualification protocols within short timelines

FUNCTIONS

• Provide technical guidance, generate reports, perform data analysis, and ensure consistent communication across technical groups, including follow-up and resolution of technical issues.


• Troubleshoot and resolve assay-related technical issues as needed.


• Ensure laboratory compliance by implementing procedures that reinforce GMP, GLP, and safety standards.


• Manage existing programs and/or develop new programs, processes, and methodologies.


• Develop, revise, and audit complex controlled documents with multi-site or multi-organizational impact.


• Approve laboratory investigations and lead audit teams.


• Serve as a subject matter expert in the development of technical training.


• Perform routine work in areas of expertise when necessary.


• Represent the department on cross-functional teams and independently manage multi-site action items.


• Interact with regulatory agencies as needed, including preparation of written responses.


• Resolve issues involving external resources when required.


• Execute special projects assigned by leadership and supervise personnel when necessary to meet technical demands.

EDUCATION REQUIREMENTS

Candidates must meet one of the following:

• Doctorate; OR


• Master’s degree + 2 years of directly related experience; OR


• Bachelor’s degree + 4 years of directly related experience; OR


• Associate’s degree + 8 years of directly related experience; OR


• High School/GED + 10 years of directly related experience.

COMPETENCIES / SKILLS

• Demonstrate and support our client’s core values.


• Excellent communication, facilitation, and presentation abilities.


• Exceptional technical writing skills.


• Strong computer proficiency (word processing, presentations, databases, spreadsheets).


• Outstanding project management and organizational skills with the ability to implement complex instructions and complete assignments independently.


• Advanced capability to manage multiple priorities and projects simultaneously.


• Extensive knowledge of quality analytical laboratory processes, validation, manufacturing, quality assurance, process development, and distribution.


• Proficiency in assay development, testing, and validation for pharmaceutical/biological products.


• Solid understanding of pharmaceutical processes and U.S. regulatory requirements, with basic knowledge of international regulations.


• In-depth understanding of GMPs, CFRs, compliance requirements, and documentation standards.


• Ability to evaluate and document compliance issues accurately.


• Proficiency in equipment maintenance, troubleshooting, and operation within area of expertise.


• Advanced scientific data analysis, data trending, interpretation, and problem-solving skills.


• Strong ability to work independently and communicate effectively across organizational levels.


• Ability to interact professionally with regulatory agencies both verbally and in writing.


• Skilled in initiating, coordinating, and leading cross-functional teams.


• Strong leadership, motivation, influence, and negotiation capabilities.