Job Overview

The Senior Quality Specialist is an expert in their assigned area and has a strong understanding of current FDA, EU and ICH requirements. This role may specialize in various aspects of technical data and documentation evaluation and review, manufacturing operations, laboratory operations, investigations, and a variety of routine and non-routine tasks. This role ensures that all QA activities are in compliance with company SOPs, GMP/GLP standards and client requirements.

This role will coordinate with appropriate departments and/or cross-functional teams to ensure all applicable documents are reviewed and released within the specified timeframes. Ability to work within a dynamic and fast paced environment.

Responsibilities
• Responsible for performing an independent quality evaluation and release of support documentation, materials, products, equipment, and facilities.
• Ensure all testing/manufacturing was performed per approved SOPs/methods/protocols and comply with specifications by critically evaluating the reported data and results for accuracy and compliance with other regulatory guidelines.
• Works independently on problems of basic to moderately complex scope in which analysis of situation or data requires a review of identifiable factors.
• Participates in department/client meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
• Foster a culture of quality and continuous improvement focused on value to the customer.
• Ability to host and/or participate in internal, client and/or regulatory audits. Works with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.
• Exercises judgment within defined procedures and practices to determine appropriate action (root cause analysis tools, CAPA, etc.) for quality events.
• Good interpersonal skills and willing to ask questions about procedures and concepts.
• Participates in the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site's needs.
• Able to be trained and train/ mentor others.
• Effectively resolves quality issues and concerns in a timely manner.
• Effectively coordinates and organizes tasks to help drive the activities of others; while performing a variety of duties on schedule, with accuracy and competency.
• Creates strong and effective working relationships with Quality team, colleagues, and clients.

Qualifications/Skills

Knowledge
• Strong attention to detail, as well as time and resource management.
• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to independently with minimal direction.
• Promote a safe environment for work.
• Communicate clearly and effectively both orally and in writing with internal and external clients.
• Working knowledge and understanding of LIMS and Empower.
• Skilled in MasterControl, Trackwise and/or other QMS software applications.
• Understanding of validation, production equipment, utilities, and/or drug development/manufacturing operations.
• Demonstrated theoretical understanding and providing effective evaluation of laboratory practices such as raw material, drug substance, drug product and medical device testing, compendia methods (e.g. USP/NF, EP, JP), and method validation/qualification/transfer, as required.

Skills / Abilities:
• Demonstrate the capability for continued upward growth and technical contributions.
• Strong analytical and problem-solving skills with proven ability to think strategically.
• Strong understanding of current FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry
• Effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
• Excellent diplomatic, analytical, and communication skills - both verbal and written.
• Recognized as a technical resource in their assigned area.
• Strong Computer Skills
• Microsoft Suite, proficiency

Education, Experience & Licensing Requirements

• Related BA/BS, required.
• 4 -6 years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in Quality Assurance.
• Experience in manufacturing operations, laboratory operations and/or QA, preferably in pharma or biotech.

Supervision Received: General Supervision

Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope.

Travel: Not Applicable

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas
for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats,
gloves, etc

The hiring range in Colorado for this position is $111,000/year - $126,000/year; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.