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

1. Self-motivated, demonstrates leadership, and works independently with minimal guidance from management.
2. High level of proficiency in problem solving, creativity, independent thought, and sound judgment.
3. Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration.
4. Training and mentoring of other members of the organization.
5. Strong performance history of consistently meeting and exceeding expectations.
6. Other duties and responsibilities may be assigned as required.

AUTHORITY

1. Take necessary action required to remedy product quality problems; such as quarantining product or shutting down production, etc.
2. Determine and request necessary resources (personnel, equipment, supplies, etc.) to effectively run the Quality Department within the manufacturing floor.
3. Hire, reward, review, discipline, and terminate personnel in the Quality Department according to company policy and applicable legal requirements.
4. Works together with other members of the management team to manage the overall direction of Surmasis.