Production Lead

Job Description Job Description 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.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 responsibilityAssist 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.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.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.