GMP Packaging Team Lead - Night shift

Merck•Saint Louis, MO

10h•$25 - $41

About The Position

The GMP Packaging Lead - Night shift at our Cherokee site, will play a key role within our GMP Operations Systems & Support team (OSS). OSS supports Manufacturing through various functions including buffer manufacturing, training, compliance, equipment and facility cleaning, packaging, and raw material sampling. The GMP Packaging Lead is responsible for overseeing and guiding GMP Packaging technicians in the preparation, execution, and reconciliation of packaging, labeling, and Raw Material Sampling events. This role requires a proactive approach to identifying and resolving issues while fostering a positive and collaborative work environment. The GMP Packaging Lead will drive compliance with all applicable regulations and maintain a safe and efficient work environment. Job duties include: Shift hours: Tuesday – Friday, 5:30pm – 3:30am.

Requirements

Bachelor’s Degree in Chemistry, Biochemistry and Biology or other scientific discipline
3+ years of experience in GMP packaging operations, manufacturing, in a pharmaceutical or biotechnology environment.
OR High School Diploma or GED
5+ years’ experience of experience in GMP packaging operations, manufacturing, in a pharmaceutical or biotechnology environment.
Ability to lift and carry materials up to [insert weight] pounds.
Ability to stand for extended periods and perform tasks requiring manual dexterity.
Wear mask, safety shoes, gloves, Tyvek suits, respirator, and related personal protective equipment

Nice To Haves

Excellent problem-solving abilities and a proactive approach to identifying and resolving issues.
Familiarity with regulatory requirements and industry best practices related to GMP packaging.
Proficient in SAP and other software applications.
Strong leadership and interpersonal skills, with the ability to motivate and guide a diverse team.
Knowledge of Lean Manufacturing principles and continuous improvement methodologies (OpEx).

Responsibilities

Execute packaging, labelling, and sampling events, in a GMP environment.
Oversee the complete packaging and labeling process, ensuring that all activities are conducted in compliance with GMP standards and regulations.
Proactively identifying and resolving operational issues, fostering a collaborative and positive team environment, and ensuring all departmental goals and objectives comply with federal, state, and company regulations.
Review new and executed Master Packaging Formulas (MPFs) for compliance and effectiveness, providing feedback and recommendations for improvements.
Assisting with the creation of accurate and complete documentation in Mango and supporting Trackwise deviations and CAPA projects through investigation interviews and timely implementation and closure of assigned corrective actions.
Provide on-the-job training (OJT) to technicians as needed and maintaining clean and organized working areas.
Key resource for continuous improvement, proposing and implementing Lean Manufacturing principles to enhance packaging processes, and developing effective corrective and preventative actions to boost operational efficiency and minimize human error.
Utilize SAP effectively in conjunction with packaging activities, ensuring accurate documentation and inventory management.
Assist the GMP Supervisor by ensuring the availability of necessary documentation, components, and support materials to adhere to the production schedule. It also involves reporting significant activities and issues in a timely manner and supporting the Supervisor with various projects and assigned duties.
Reviewing production documentation like MPFs, OPs, and logbooks for compliance and effectiveness, providing feedback for improvements, and managing multiple tasks and priorities while balancing functional responsibilities with communications and meetings.
Collaborate cross-functionally with Quality Control, Quality Assurance, Materials Management, Engineering, and Maintenance to ensure seamless operations.
Understanding key performance indicators (KPIs) to drive continuous improvement in packaging operations and participating in regular safety and quality audits, demonstrating compliance in these areas.