Aseptic GMP Process & CAPA Specialist

INCOG BioPharma Services; Fishers (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Professional development opportunities

On-site fitness facilities

Job summary

INCOG BioPharma Services in Fishers, IN is seeking a Process Specialist to collaborate with operations and quality systems to support deviation investigations and CAPA implementation. You will bring aseptic manufacturing knowledge as a SME and lead cross-functional process improvements while ensuring quality outcomes.

The role emphasizes strong communication, data-driven investigation writing, and the ability to influence without direct authority in a fast-paced environment at our Fishers site.

Qualifications

• 4 years minimum experience working in a GMP environment.
• Batch record and associated manufacturing report review experience.
• Deviation and technical writing experience.
• Client and Regulatory Agency audit experience.
• Excellent written and verbal communication skills.
• General computer skills with data analysis software (Word, Excel, Visio, JMP, Minitab).

Responsibilities

• Authoring, reviewing, and approving SOPs & Work Instructions; create news to improve efficiency if needed.
• Directs or conducts studies to ascertain the best sequence of operations or workflow.
• Review employees and department productivity; develop action plans to improve performance.
• Maintain effective communication with other departments and employees.
• Lead root cause analysis activities using fishbone diagrams, 5 Whys, and statistical analysis.
• Participate in cross-functional teams to advance project activities.
• Support equipment/process FMEAs to understand risks.
• Ensure data integrity in batch records using automated systems.

Skills

Process control

Quality engineering

Statistical techniques

GMP knowledge

Quality systems

Cross-functional collaboration

Documentation writing

Tools

SCADA

BMS

CMMS

LIMS

Excel

JMP

Minitab

Job description

INCOG BioPharma Services in Fishers, IN is seeking a Process Specialist to collaborate with operations and quality systems to support deviation investigations and CAPA implementation. You will bring aseptic manufacturing knowledge as a SME and lead cross-functional process improvements while ensuring quality outcomes.

The role emphasizes strong communication, data-driven investigation writing, and the ability to influence without direct authority in a fast-paced environment at our Fishers site.