QC Scientist – Critical Reagents

JOB SUMMARY

The QC Scientist – Critical Reagents is responsible for overseeing all reference standards and other critical reagents in line with internal SOPs and ICH guidelines. This individual will work collaboratively with QC Operations, Analytical Development, and Quality Assurance in support of clinical pipeline and commercial products. This position requires strong leadership skills, statistical and technical knowledge, and a commitment to quality and compliance

ESSENTIAL JOB FUNCTIONS

• Oversee the Critical Reagents and Materials function.
• Oversee the day-to-day operations of the GC QC Technical Services group.
• Provided operational oversight for critical reagent and materials management across the quality organization.
• Develop and maintain robust systems for the qualification, monitoring, tracking and storage of critical reagents and materials.
• Collaborate with cross-functional groups to ensure the continued supply of qualified reagents and materials.
• Act as the primary point of contact for the monitoring, tracking, and storage of critical reagents and materials.
• Manage inventory, strategic planning, and lifecycle management of reference standards and critical materials.
• Represent Quality Control on project teams and in meetings as required.
• Authors and reviews standard operating procedures, protocols, and reports as required.
• Manages the implementation/maintenance/continuous improvement of Quality Systems as required.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

|————————————————————————————————————————————|———————–|
| EDUCATION / CERTIFICATIONS / LICENSES | Essential/Desired |
| BS or MS in Life Sciences or Engineering | Essential |
| ON-THE-JOB EXPERIENCE | |
| 8 years of pharma/biotech industry experience | Essential |
| Well versed in cGMP/ICH/FDA/EU regulations and guidelines | Essential |
| Large molecule, gene or cell therapy experience is required. | Essential |
| Expertise in reference standards programs, including ICH regulations and quality control methods. | Essential |
| Strong background in biostatistics for evaluation comparability and qualification of new reference standards and control reagents. | Desired |
| Experience in Quality Control within the biological pharmaceutical industry. | Desired |
| Proficiency in writing SOPs, qualifications protocols, and reports. | Essential |
| Familiarity with statistical software (JMP). | Essential |
| SKILLS / ABILITIES | |
| Excellent analytical and problem-solving skills | Essential |
| Must possess excellent communication and organizational skills | Essential |
| Cross functional collaboration ability to work well with diverse groups | Essential |
| Ability to manage multiple activities with challenging timelines | Essential |
| Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint) | Essential |
| Effective oral and written communication skills | Essential |
| Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards | Essential |
| Exhibits highest integrity and committed to ethics and compliance standards | Essential |
| Open and transparent in sharing data and information | Essential |

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 25 pounds
• Occasionally lift and/or move up to 50 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail