Sterile Manufacturing Operator Lead 503B (2nd shift)

Empower Pharmacy; Houston (TX); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical company in Houston, TX, is seeking a Sterile Manufacturing Operator Lead to oversee sterile manufacturing in a cGMP environment. Responsibilities include leading processes, analyzing production data, training staff, and ensuring adherence to quality standards. Minimum 1 year compounding experience and a High School Diploma are required. Comprehensive benefits include medical, dental, and 401(k) matching.

Benefits

Medical coverage

Dental coverage

Vision coverage

401(k) matching

Wellness perks

IV therapy

Compounded medications

Qualifications

• Minimum of 1 year compounding experience required.

Responsibilities

• Leads sterile manufacturing processes to ensure quality and efficiency.
• Analyzes production data to identify trends and implement improvements.
• Maintains cGMP environment through cleaning and disinfecting.
• Trains new hires and manages workforce allocation.
• Reviews batch records and addresses non-conformances.

Skills

Attention to detail

Self-motivation

Teamwork

Leadership or mentoring experience

Excel proficiency

Education

High School Diploma or equivalent

Job description

Overview

The Sterile Manufacturing Operator Lead oversees sterile manufacturing in an ISO-classified current Good Manufacturing Practice (cGMP) environment, ensuring quality and efficiency. This role supports Empower’s mission to deliver affordable, high-quality medications.

Responsibilities

• Leads sterile manufacturing processes, including preparation, mixing, and aseptic vial filling, while ensuring adherence to schedules and daily operations.
• Analyzes production data to identify trends, ensure quality, and implement continuous improvement initiatives.
• Maintains an ISO-classified cGMP environment through cleaning, disinfecting, and sterile compounding.
• Trains new hires, manages workforce allocation, resolves equipment issues, and ensures compliance with standard operating procedures.
• Reviews batch records, maintains documentation, and addresses non-conformances to uphold product quality.

The employee may be required to communicate verbally and in writing, stay in a stationary position for portions of the workday, and use computers and other devices. The role may involve movement around the office and corporate campus, standing, walking, reaching, climbing or balancing, and kneeling or crouching as part of daily activities.

Knowledge and Skills

• Demonstrates strong attention to detail, self-motivation, and teamwork, with the ability to work effectively in a controlled environment and follow detailed instructions.
• Proficiency in Excel or other spreadsheet software, basic math skills, and experience in a lead or mentoring role is preferred.

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer-centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high-quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the needs of different audiences.

Values

• People: Our people define who we are as a company, and understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

Experience and Qualifications

• Minimum of 1 year compounding experience required.
• High School Diploma or equivalent required.

Benefits

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Management and Manufacturing

Industries

• Pharmaceutical Manufacturing

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