JOB SUMMARY

The Quality Control Specialist II/III, External Testing and Program Management supports the day-to-day quality operations within the QC Lab Operations group as the Quality Control (QC) representative and subject matter expert (SME) for both internal teams and external clients, ensuring the effective management of all external testing activities and alignment with client requirements. This includes overseeing the planning, coordination, and execution of outsourced testing, method qualifications, and assay transfers, while maintaining compliance with quality standards and timelines. The role is also responsible for managing QC-related client communications, authoring and resolving deviations and investigations, reviewing and approving key quality documents, and supporting cross-functional QC initiatives. Additionally, the position manages contracts, budgets, and sample logistics associated with external testing, and contributes to process improvements and strategic QC operations to ensure data integrity, regulatory compliance, and client satisfaction.

ESSENTIAL JOB FUNCTIONS

• QC rep for internal and client communication, attending client meetings and managing all QC/client interaction 
• Author testing investigations/deviations, including operational DEV, CC, and CAPAs 
• QC SME for impact assessments with client impact
• Creation, review and approval of quality documents including Sample Plans, Specifications, CoAs, CoTs, Stability, Protocols and Reports
• Manage method qualifications and assay transfers to/between CTLs, support program method transfers as needed 
• Cross-functional QC support as needed to support client requirements  
• Request SOW/Quote per project; submit PO for testing services
• Provide vendor PO# for their invoice and signed contract
• Refer to MPS for schedule of all project samples-forward to vendor
• Coordinate client sample shipping w/ QCSM to client CTLs and client for routine testing and stability programs 
• Track and manage all external testing data to meet client TAT
• Review, compile, scan, and archive CTL CoA
• Prepare Release forms and generate DS/DP COA
• Coordinate w/ CTL to manage contracts, testing, timelines, investigations and process improvements
• Manage and monitor Critical Reagent usage and spend
• Manage and monitor External testing shipments and spend
• Report Monthly spend readouts to Finance
• Attending/supporting kick-off, routine client meeting

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 in Life Sciences, Chemistry, Analytical, or other related science

Essential

ON-THE-JOB EXPERIENCE

 

4 – 10 years of relevant GMP experience

Essential

Follows procedures trained on and complete documentation applying cGMP/GDP/ALCOA+

Essential

Thorough understanding of industry requirements/standards

Essential

Experience working with clients including communications, attending meetings and managing client interactions

Essential

Conducted/Completed client impact assessments

Essential

Experience managing multiple clients with extremely tight deadlines

Essential

SKILLS / ABILITIES

 

Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.)

Essential

This role is client facing and requires multiple meetings so excellent oral and written communication, organizational and time management skills with the ability to work well with otehrs/Clients and independently

Essential

Attention to detail and able to multi-task with challenging timelines

Essential

Exhibits critical thinking, understand and uses project management tools

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

Pay Range:
The annual salary range for this position by level is as follows:
      Specialist II: $80,000-$95,000
      Specialist III: $90,000-$105,000

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success. 

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary, vested immediately
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

• Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. 

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.