Senior Manufacturing Lead cGMP/ISO, Onsite

TekWissen LLC; Lenexa (KS); On-site; USD 34,000 - 52,000; Part time

Job summary

TekWissen Group is seeking a Senior Manufacturing Associate to join our client in Lenexa, KS, on a 6‑month onsite assignment with a weekend day shift (Fri–Sun, 06:00 AM–06:30 PM). You will lead daily manufacturing operations in a regulated environment, ensuring safety, quality, and compliant execution of activities.

The candidate should have strong knowledge of cGMP and ISO standards, experience reading batch records and SOPs, mentoring team members, and driving continuous improvement while

Qualifications

• High School Diploma or GED required.
• 4 years of manufacturing experience with demonstrated leadership capabilities.
• Engineering, Chemistry, Biology, or related field preferred.
• Technical certification in manufacturing or a relevant field is beneficial.
• Strong knowledge of cGMP, ISO standards, and regulatory requirements.
• Expert ability to read and interpret manufacturing documentation, SOPs, and technical specifications.
• Advanced troubleshooting and problem-solving skills related to manufacturing equipment and processes.
• Experience implementing continuous improvement initiatives and lean manufacturing practices.
• Strong communication and interpersonal skills with the ability to lead and mentor team members.
• Proficiency with manufacturing software systems, ERP platforms, and Microsoft Office Suite.
• Experience with documentation and batch record review in regulated environments.
• Ability to strictly follow safety protocols and maintain cleanroom/controlled-environment standards.
• Demonstrated ability to coordinate cross-functional teams and manage multiple priorities.
• Exceptional attention to detail and commitment to quality standards.
• Strong analytical and decision-making capabilities.
• Experience training and developing team members.
• Ability to stand for extended periods, lift up to 50 lbs, and work while wearing required PPE.
• Flexibility to work various shifts and overtime as needed.

Responsibilities

• Lead and support day-to-day manufacturing operations while ensuring adherence to safety, quality, and production requirements.
• Read, interpret, and follow manufacturing documentation, SOPs, technical specifications, and batch records.
• Review and maintain manufacturing documentation and batch records in accordance with regulated-environment requirements.
• Troubleshoot manufacturing equipment and processes and identify appropriate solutions to operational issues.
• Implement and support continuous improvement initiatives and lean manufacturing practices.
• Train, mentor, and support the development of team members.
• Coordinate activities across cross-functional teams and effectively manage multiple priorities.
• Ensure compliance with cGMP, ISO standards, regulatory requirements, and established quality procedures.
• Maintain cleanroom and controlled-environment standards while following required PPE and safety protocols.
• Utilize manufacturing software systems, ERP platforms, and Microsoft Office tools as required.
• Maintain a strong focus on product quality, accuracy, documentation, and attention to detail.
• Support operational decision-making and resolve manufacturing issues using analytical and problem-solving skills.
• Work scheduled shifts and overtime as needed to support manufacturing operations.

Skills

cGMP knowledge

ISO standards

Batch records

Leadership

Troubleshooting

Documentation

Lean manufacturing

ERP systems

MS Office

Safety protocols

Cross-functional coordination

Education

High School Diploma or GED

Engineering/Chemistry/Biology background preferred

Tools

ERP platforms

Microsoft Excel

SOP documentation

Job description

TekWissen Group is seeking a Senior Manufacturing Associate to join our client in Lenexa, KS, on a 6‑month onsite assignment with a weekend day shift (Fri–Sun, 06:00 AM–06:30 PM). You will lead daily manufacturing operations in a regulated environment, ensuring safety, quality, and compliant execution of activities.

The candidate should have strong knowledge of cGMP and ISO standards, experience reading batch records and SOPs, mentoring team members, and driving continuous improvement while