Actalent is Hiring a Senior Specialist QA Lab Tech

(Brownsburg, IN)

Description:

Seeking a Sr. Specialist, QA for ATLab Indianapolis, a new state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability. This role should set a strong example for other personnel at ATLab Indianapolis of determination to overcome obstacles, striving toward ambitious goals and timelines for this new facility, and a service-oriented focus on helping cancer patients.

As the facility is not yet built, the Senior Production Operator will focus on different area's throughout the building progression:

1) Setup Phase

• Documents: Draft/review/approve SOPs, other QA documents (SVMP, QAAs, FMECA, Risk Analysis)
• Review IQ/OQ/PQ for new cleanrooms, equipment, software
• Tech transfer: PV runs, final reports
• Vendor qualification

2) Production Phase

• Top Priority: Batch Release
• Document Control: Release batch record/QC test records
• Materials: Release from Controlled Storage
• Manufacturing floor: maintain QA presence; process confirmation
• Prompt review of documents for batch release
• React to urgent problems
• Operational line clearances/AQL inspections

3) QA Functions

• Equipment: Review completed PM/RQ
• Review GMP documents (records, equipment/service logs, certificates)
• Expert on QMS: speak to management/inspectors
• Materials: Inspect; Review COAs/acceptance sheets
• Document Control
• Qualify staff:

o Read & Understand

o Production: gowning, media fills, process

o Training matrix

4) Continuous Improvement

• Work with Production/QC/Shipping teams for mutual improvement
• Internal audits, FMEAs
• Oversee investigations to resolve equipment/process deviations/OOS/recalls/complaints
• Coordinate CAPAs/Change Controls; effectiveness evaluation
• Prioritize time in balancing production timelines with product quality assurances
• Continue duties from Project Phase as needed

5) Leadership

• Set tone in QA Team
• Embody/promote culture of quality with continuous improvement
• Example of determination, problem solving, servant leadership
• Lead toward ambitious goals/timelines

Skills:

Aseptic, Pharmaceutical, GMP, Laboratory, Quality Assurance, Six sigma, Process improvement, Batch Record, cGMP, Cyclotron, Particle Accelerator, Sample Prep, Clean Room, radiopharmaceutical, nuclear medicine, isolator, sterile environment, sterile manufacturing, vendor qualification, method development

Additional Skills & Qualifications:

Must Haves:

1) B.S. or B.A. Degree in Life Science or related field

2) 1+ year of experience working within clean rooms or an aseptic environment

3) 2+ years of QA experience within pharma industry OR 3+ years of QA experience within regulated industry (food/bev, cosmetic, etc.)

Nice To Have:

1) Radiopharmaceutical experience

2) FDA Submission (IND, DMF, NDA)

3) Software: eQMS, eBR, LIMS, BMS

4) New facility: new systems, construction, qualification

Experience Level:

Intermediate Level

SCHEDULING INTERVIEWS ASAP

• Reach out directly and apply to Sydney Brooks to be immediately in consideration for our current opportunities with your updated resume, a brief intro about you and your skills, and what method of communication works best for you (i.e., call, email, text)
• DIRECT LINE: 317- 567-6625

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.