Quality Control Specialist (Regulated Industry) 3562859

ProQuality Network; United States; Hybrid; USD 85,000 - 120,000; Full time

Job summary

ProQuality Network seeks a Quality Control Specialist (Regulated Industry) to act as technical lead for testing in molecular biology and microbiology. The role focuses on complex issues across multiple sites and with outside resources, ensuring GMP and GLP compliance.

Responsibilities include guiding technical groups, data analysis, lab investigations, audits, and potential SME training. Strong communication and documentation skills are essential, with extensive knowledge of pharmaceutical

Qualifications

• Requires advanced knowledge of GMP, GLP and safety protocols.
• Proven ability to develop and audit complex controlled documents with multi-site impact.
• Extensive knowledge of pharmaceutical/biological testing and regulatory practices.

Responsibilities

• Provide technical guidance, reports and data analysis across multiple groups.
• Troubleshoot assays and resolve technical issues as needed.
• Ensure lab compliance and implement procedures to enhance GMP/GLP compliance and safety.
• Lead cross-functional teams and audit processes.
• Develop and supervise training and investigations as required.
• Interact with regulatory agencies when needed and manage multi-site action items.

Skills

GMP

Regulatory knowledge

Data analysis

Technical writing

Project management

Cross-functional teamwork

Troubleshooting

Quality systems

Communication

Auditing

Education

Doctorate

Master's + related experience

Bachelor's + related experience

Associates + related experience

High school/GED + 10 years experience

Job description

Quality Control Specialist (Regulated Industry) 3562859

Title: Quality Control Specialist (Regulated Industry) 3562859

Work Modality: 100% Onsite

Schedule: Administrative and Non-Standard Shifts (as required)

Type: Contract Position (Approximately 5 Months)

Open Positions: 1

SUMMARY

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.

Preferred Qualifications:

Engineering (Chemical, Environmental, Mechanical, Electrical), or Chemist/Biology (with experience in Equipment Validation)

Laboratory Equipment Validation

• o Periodic Monitoring
• o Periodic Review
• o Equipment Data Integrity
• o Equipment Procurement
• o New equipment Introduction and Maintenance
• o Others:

Biochemistry (eg. Compendial testing, physical methods)

Microbiology (eg. Sterility, Endotoxin, Bioburden)

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 OR
• Bachelors + 4 years of directly related experience OR
• Associates + 8 years of directly related experience OR
• 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.