DES MOINES / IA

Katecho, Inc.; Des Moines (IA); Hybrid; USD 23,000 - 32,000; Full time

Benefits offered by this job

Medical Insurance

Dental & Vision

FSA

Life Insurance

STD/LTD

401(k)

Job summary

Surmasis Pharmaceutical seeks a Quality Lead II to supervise in the cleanroom and manufacturing areas, ensuring GMP conformity and providing guidance to staff. The role involves overseeing quality checks on in-process and finished goods, reviewing documents for SOP adherence, and maintaining accurate records.

Strong organizational skills, attention to detail, and the ability to work with minimal supervision are essential for success in this fast-paced environment.

Qualifications

• Leadership by example in attitude, work quality and communication.
• Ability to read and understand product criteria on engineering drawings.
• Ability to train and supervise employees and manage multiple activities.

Responsibilities

• Lead a team to complete duties in a timely, safe manner.
• Perform quality verifications and sampling for batch manufacturing.
• Review documents to ensure GMP and site SOP compliance.
• Identify, investigate and report quality issues.

Skills

Leadership

Communication

Reading drawings/criteria

Training employees

Independent work

English proficiency

Documentation accuracy

Time management

Background check

Position assessment

Education

High school diploma or equivalent

Job description

Surmasis Pharmaceutical- Quality Lead II |Mon-Wed 7am - 7pm | $20.00 per hour

• Job Tracking ID:512885-901989
• Job Location:DES MOINES, IA
• Job Level:Entry Level (less than 2 years)

The Quality Lead ensures that all products are manufactured inaccordance with current Good Manufacturing Practices (GMP) and meetall internal specifications. This position will spend the majority ofits time in the Surmasis cleanroom/manufacturing areas providingoversight and guidance to manufacturing personnel in the performanceof their duties. This position is also responsible for performing anumber of quality assurance checks on in-process products and finishedgoods. This position is responsible for reviewing documents to ensurethat they were completed in accordance with current GMP and site SOPs.Strong organizational skills and the ability to prioritize work andrespond to customer demands in a timely fashion are criticalrequirements of this position.

Responsibilities include leading department employees to completeassigned duties in a timely manner while working safely as aneffective member of the team. Leads must have good math skills, anattention for detail and the ability to work independently withminimal supervision. The Lead must also ensure accurate completion ofassociated documents and records. Requires the ability to direct andtrain employees as well as monitor multiple processes simultaneously.

PRIMARY DUTIES AND RESPONSIBILITIES

• Leads a team of people by example in the areas of attitude, workquality, work ethic, dependability, and communication.
• Supports batch manufacturing activities by performing qualityverifications and sampling plans.
• Reviews documents to ensure they meet GMP and site SOP requirements.
• Identifies, investigates, and prepares reports on quality issues.
• Performs line clearance, inspections, and physical testing inmanufacturing areas.
• Interprets generated data and communicate results to Quality management.
• Maintains effective communication and partnership withmanufacturing and quality systems department.
• Maintains quality standards in all tasks performed.
• Adapts to changes in the work environment and must be able tochange shifts or work overtime and/or weekends as needed.
• Handles fast pace working environment which may require switchingbetween multiple manufacturing rooms within a single day.
• Leads employees and provide direction to complete required tasks.
• Follows applicable procedures, instructions, engineering drawingsand training.
• Trains employees according to departmental training requirements
• Monitors employees in their jobs and assist as necessary.
• Answers employee questions involved with the Lead’s respective area.
• Interfaces with supervision and/or management to ensure assignedduties are completed accurately. This may include interfacing withemployees in other departments.
• Works as an effective member of the team.
• Ensures area is clean, organized and well maintained.
• Completes all documents and records required.
• Participates in investigations on non-conforming product, as necessary.
• Raw material receipt verification, sampling, and CofA generation.
• Raw material kit verifications for kit going to/from manufacturing room.
• Maintains 5S, especially regarding cleanliness and organization ofwork cell.
• Trains and mentors other leads.
• Reads, follows, and understands standard operating procedures.
• Other duties and responsibilities may be assigned as required.

AUTHORITY

• Trains lower-level employees in the Lead’s respective area.
• Interfaces with other departments as necessary.
• Works on continuously improving the organization and function ofthe department by suggesting procedural improvements.
• Stops manufacturing line should a quality defect be identified andneed addressed.

Experience and Skills:

QUALIFICATIONS

• High school diploma or equivalent required.
• Able to lead and influence others by example in the areas ofattitude, 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 anaccurate 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 tocomplete 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.

PHYSICAL DEMANDS

The physical demands described here are representative of those thatmust be met by an employee to successfully perform the essentialfunctions of this job. Reasonable accommodations may be made to enableindividuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequentlyrequired to stand, walk, sit, and operate a computer. The employee isregularly required to use hands to grasp, finger or handle objects andreach with hands and arms. The employee is frequently required to talkand hear. Specific vision abilities required by this job include closevision, distance vision, and color determination. This employee mustoccasionally lift and /or exert force from 25 up to 75 pounds. Pushand/or pull up to 300 pounds.

WORK ENVIRONMENT

Majority of time spent working in the manufacturing floor.

At Surmasis, we’re proud to offer a comprehensive benefits package, including:

• Medical Insurance – PPO & HMO plans
• Dental and Vision Coverage
• Flexible Spending Account (FSA)
• Life Insurance Options
• Short-Term and Long-Term Disability (STD/LTD)
• 401(k) Retirement Plan

We believe in taking care of our team—so you can focus on doing yourbest work.