Production Lead

3 weeks ago

Denver, United States STAQ Pharma Full time

STAQ Pharma is currently looking to hire a pharmaceutical production lead to join our team in the Denver, CO area. This individual will be responsible for overseeing 15-20 production technicians during the shift, as well as support all aspects of production that include batch kitting, formulation, aseptic filling, inspection and labelling.

The shift is working Monday to Friday, 6 AM until DONE

Pay: $25-$26, DOE

STAQ Pharma offers a great work environment, opportunity for growth and advancement as well as opportunity to learn more from the pharmaceutical industry

Summary

The Production Lead’s responsibilities include:

· Supporting all aspects of Production for sterile drug products, overseeing Production Technicians and performing technician duties such as batch kitting, formulation, aseptic filling, inspection and labeling.

· Overseeing implementation and compliance with STAQ Quality Systems (includes SOPs, WIs, etc.), continuous quality improvement activities, etc.

· Ensuring compliance current Good Manufacturing Practices (cGMP), and applicable regulatory (e.g., FDA, DEA, BoP, OSHA) requirements and guidance.

Roles & Responsibilities

· Assist employees who are responsible for product formulation, aseptic filling, inspection and labeling, or facility cleaning and disinfection.

· Demonstrate mastery and provide formal training and education to employees in areas of good documentation practices, gowning, formulation, aseptic filling, and other applicable production processes.

· Demonstrates and serves as an example to others safe work culture including PPE use, chemical and material handling.

· Perform equipment calibrations according to SOPs and troubleshoot equipment as needed.

· Coordinate with leadership on Production schedule and ensure daily tasks and resources are allocated to support schedule and achieve Production goals.

· Provide leadership with a focus on creating and maintaining a positive work environment through effective communication and positive training experiences. Mentor team members and support career advancement within the organization.

· Participate in the creation, review, and revision of procedures, policies, and other quality documents that pertain to Production.

· Identify and analyze production efficiencies, downtime, and waste. Lead and encourage teams to improve results and production output.

· Exercise discretion, judgment, and personal responsibility

· Assist with writing non-conformances that occur in the department. Assist Quality to quickly resolve any variance or document errors so that product may be released on time.

· Supports technical teams such as engineering, R&D, facilities, etc. in their activities and goals.

· Demonstrate ability to lift/push/pull a minimum of 50 pounds.

· Demonstrates ability to stand and walk for extended periods of time.

Preferred Qualifications and Education

· High School Diploma or GED required.

· Minimum 5 years of general work experience.

· Minimum 3 years of experience in a cGMP FDA regulated manufacturing environment; 2 or more years aseptic processing preferred.

· Computer literate in Microsoft Office (PowerPoint, Excel, Word)

· Knowledge of cGMP requirements and guidance.

· Ability to perform basic pharmaceutical calculations.

Preferred Skills

· Experience with gowning and aseptic processing in a manufacturing setting.

· Demonstrated effective and respectful interaction skills and a measurable track record of influence at all levels of an organization.

· Organizational, motivational, and analytical problem solving skills.

· Excellent written and verbal communication skills.

· Ability to work in a fast-paced environment with dynamic priorities and demands.

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