Quality Manager - Manufacturing | Monday - Friday| Pay Based on Experience
+ + Job Tracking ID: 512885-879718
Job Location: DES MOINES, IA
Job Level: Management
Level of Education: BA/BS
- Job Type: Full-Time/Regular
Date Updated: May 23, 2024
Years of Experience: 2 - 5 Years
Starting Date: ASAP
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Job Description:
Job Summary
The Quality Manager - Manufacturing will oversee, manage, coordinate and prioritize the daily activities of the Quality personnel on the manufacturing floor. They will monitor and implement the Quality Systems to ensure compliance with the cGMP’s and work in partnership with manufacturing operations, quality control and assurance, engineering, maintenance and other support areas to solve problems and provide expertise on compliance issues and corporate quality policy requirements.
PRIMARY DUTIES AND RESPONSIBILITIES
1) Manage the quality manufacturing staff (quality leads and quality inspectors) and daily quality functions of:
a) Raw material receipt and sampling.
b) 100% real time visual inspections on manufacturing lines.
c) Conduct Sampling Plans of: AQL inspections, in process/finished product sampling and stability samples.
d) Environmental monitoring of water systems, clean rooms and equipment cleaning swabs.
e) Real-time review of executed batch records.
2) Ensure adherence to cGMP regulations and internal procedures.
3) Maintains a high level of understanding of relevant manufacturing processes and quality systems related to 21 CFR 210/211 and Part 820 (applicable sections for combination products).
4) Perform deviation/incident investigations including root cause analysis and CAPA implementation.
5) Address quality issues and implement solutions.
6) Collaborate with the Manufacturing and Engineering departments.
7) Write and maintain Standard Operating Procedures.
8) Support and/or perform qualifications of equipment/processes.
9) Support and/or perform process validations as the primary Quality Manufacturing representative.
10) Understand and apply moderately complex mathematical concepts, to include statistics, in support of continuous improvement and statistical process control efforts.
11) Drive a culture of quality and continuous improvement.
12) Lead and delegate tasks and projects to team members.
13) Regular and reliable attendance is an essential function of this job. Punctuality and regular attendance is crucial for efficient plant operations, safety and morale.
SECONDARY DUTIES AND RESPONSIBILITIES
Self-motivated, demonstrates leadership, and works independently with minimal guidance from management.
High level of proficiency in problem solving, creativity, independent thought, and sound judgment.
Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration.
Training and mentoring of other members of the organization.
Strong performance history of consistently meeting and exceeding expectations.
Other duties and responsibilities may be assigned as required.
AUTHORITY
Take necessary action required to remedy product quality problems; such as quarantining product or shutting down production, etc.
Determine and request necessary resources (personnel, equipment, supplies, etc.) to effectively run the Quality Department within the manufacturing floor.
Hire, reward, review, discipline, and terminate personnel in the Quality Department according to company policy and applicable legal requirements.
Works together with other members of the management team to manage the overall direction of Surmasis.
Experience and Skills:
QUALIFICATIONS
The ideal candidate will have a BS degree in an engineering, scientific position or related field with preferred 4 years of experience in Quality or Engineering position, with direct experience working in a FDA regulated/GMP manufacturing environment.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to stand, walk, sit and operate a computer. Specific vision abilities required by this job include close vision and distance vision.
WORK ENVIRONMENT
Office environment with business casual dress. May require business attire.
Benefits
PTO awarded immediately.
7 paid holidays, including New Year, Memorial Day, 4th of July, Labor Day, Thursday & Friday for Thanksgiving, Christmas Day.
Full benefits, including Medical, Dental, Vision, STD, LTD & Life options, and 401K plan available.