Quality Lead II — GMP Compliance & Line Oversight

Katecho LLC; Des Moines (IA); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Medical Insurance - PPO & HMO plans

Dental and Vision Coverage

Flexible Spending Account (FSA)

Life Insurance Options

Short-Term and Long-Term Disability (0

401(k) Retirement Plan

Job summary

Surmasis is seeking a Quality Lead to ensure GMP-compliant manufacturing and adherence to internal specs. You will oversee manufacturing personnel in cleanroom areas, perform QA checks on in-process and finished goods, and review documents for GMP and SOP alignment.

Strong organization and ability to prioritize and respond to customer demands are essential. The role requires leading a team, training staff, performing line clearance and data interpretation, and maintaining 5S and clean,

Qualifications

• High school diploma or equivalent required.
• Able to lead and influence others by example in the areas of attitude, work quality, work ethic, dependability, and communication.
• Able to read and understand the product criteria on engineering drawings.
• Able to direct and train employees.
• Able to supervise multiple activities or jobs simultaneously in an accurate manner.
• Able to work and communicate well with others.
• Able to read and write English.
• Good work attendance and dependability.
• Excels in working independently and maintaining self-motivation to complete work.
• Knowledge of various controls and procedures such as error rates, shortages, and cycle counting.
• Must be able to work with minimal supervision.
• Must be able to pass a background check.
• Must be able to complete a position assessment test.

Responsibilities

• Leads a team of people by example in attitude, work quality, work ethic, dependability, and communication.
• Supports batch manufacturing activities by performing quality verifications and sampling plans.
• Reviews documents to ensure GMP and SOP requirements.
• Identifies, investigates, and prepares reports on quality issues.
• Performs line clearance, inspections, and physical testing in manufacturing areas.
• Interprets generated data and communicate results to Quality management.
• Maintains effective communication and partnership with manufacturing and quality systems department.
• Maintains quality standards in all tasks performed.
• Adapts to changes in the work environment and may require shift changes/overtime/weekends.
• Handles fast-paced environment with switching between rooms.
• Leads employees and provide direction to complete tasks.
• Follows procedures, instructions, drawings and training.
• Trains employees according to departmental training requirements.
• Monitors employees and assists as necessary.
• Answers employee questions involved with the Lead's area.
• Interfaces with supervision/management to ensure duties are completed accurately.
• Works as an effective team member.
• Ensures area is clean, organized and well maintained.
• Completes all documents and records.
• Participates in investigations on non-conforming product as necessary.
• Raw material receipt verification, sampling, and CofA generation.
• Raw material kit verifications for kit to/from manufacturing room.
• Maintains 5S, cleanliness and organization of work cell.
• Trains and mentors other leads.
• Reads, follows, and understands SOPs.
• Other duties may be assigned.

Skills

Leadership

Attention to detail

Reading engineering drawings

Training others

Multi-tasking

English writing

Attendance

Background check

Education

High school diploma

Job description

Surmasis is seeking a Quality Lead to ensure GMP-compliant manufacturing and adherence to internal specs. You will oversee manufacturing personnel in cleanroom areas, perform QA checks on in-process and finished goods, and review documents for GMP and SOP alignment.

Strong organization and ability to prioritize and respond to customer demands are essential. The role requires leading a team, training staff, performing line clearance and data interpretation, and maintaining 5S and clean,