Quality Control Supervisor-10Am To 6:30Pm

SUMMARY

The Quality Control Supervisor is responsible for the overall direction, coordination, and evaluation of the QC unit.

Quality Control Supervisor is responsible for setting the standard for professionalism in the workplace at Wells Pharma of Houston.

This position supervises the daily function of Quality Control: Release of raw materials and finished product, EM & Microbiology laboratory, Retains, Analytical data, Batch Release and monitoring of cleanroom controls relating to the HVAC system.

ESSENTIAL DUTIES AND RESPONSIBILITIES

· Oversee the environmental monitoring (routine and production) program for the facility. This includes but is not limited to EMPQ, establishment of sampling plans, routine trending, and excursion response procedures in accordance with applicable regulatory guidelines.

· Leads environmental excursion investigations. Ensures corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the trending meetings.

· Prepares responses to audits, deviations, out of specification/lab investigations, and corrective/preventative actions (CAPA).

· Participate in the management of associated Quality Systems, monitoring effectiveness of Quality Systems and providing updates to Senior Quality management.

· Author and revise appropriate SOPs through review, revision and approval processes.

· Assist with ensuring QC policies and procedures/work instructions are followed correctly.

· Assist with ensuring all duties in designated GMP areas are in adherence with ISO standards, cGMP, and current industry compounding practices.

· Manage the gown qualification program.

· Familiarity with quality standards and processes to follow federal, state, and local regulations

· Knowledge of the product to perform accurate Quality Control testing and product release

· Analysis, critical-thinking and problem-solving skills to review systems, find non-conformances

· Ability to operate under deadlines while still meeting standards

· Ensuring that products adhere to quality standards and generating COAs for release product

· Preparing non-conformance reports by collecting, analyzing and summarizing data

· Training and managing Quality Control staff in environmental monitoring practices

· Implementing methods to inspect, test and evaluate products and production

· Complete other duties as requested by senior management.

Other management Tasks Include (but are not limited to):

· Develop and maintain a tool for monitoring QC resource capacity. Provides feedback to Quality senior management when capacity constraints exist.

· Develop and monitor team performance measures to understand effectiveness & efficiency.

· Sets and deliver on individual and team goals that support the department and site strategy

· Operate as a mentor and trainer to QC staff in and out of the cleanroom in relation to (but not limited to) aseptic technique, EM, cGMP, deviation prevention, etc.

QUALIFICATIONS:

· An individual must be able to perform each essential duty satisfactorily.

EDUCATION AND/OR EXPERIENCE:

· Bachelor’s degree in Science or Engineering, or, Associate Degree with 2 to 5 years of related experience.

· Very strong understanding of GXP as it pertains to 21 CFR 210, 211 and 503B regulated environments.

· A fundamental, working knowledge of safety, quality systems, and Quality Control concepts is required

· Ability to complete tasks with little direction or need for supervisory follow-up

· Strong written, verbal and presentation communication skills.

· Strong computer skills in Word, PowerPoint, Excel, and other must be able to learn additional software, as required

· Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards

· Ability to complete tasks with little direction or need for supervisory follow-up

Working knowledge of Microbiology as it related to 21 CFR parts: 503B, 210, 211 and other related regulatory and industry standards

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Do you have a Bachelor’s degree in Science or Engineering, or, Associate Degree with 2 to 5 years of related experience? Required
• Do you have a very strong understanding of GXP as it pertains to 21 CFR 210, 211 and 503B regulated environments? Required
• Do you have a working knowledge of Microbiology as it related to 21 CFR parts: 503B, 210, 211 and other related regulatory and industry standards? Required

Work Location: In person