Production Lab Tech Lead

Merck Gruppe; St. Louis (MO); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a Production Lab Tech II to join their team in a dynamic manufacturing environment. This role involves performing various technical duties, including manufacturing, filling, labeling, and maintaining compliance with quality standards. The ideal candidate will have a high school diploma and at least one year of experience in a production setting. This is an excellent opportunity for individuals looking to grow their careers in a regulated biotechnology or pharmaceutical environment. Join a company that values teamwork, quality, and continuous improvement, and make a difference in the industry.

Qualifications

• 1+ years of experience in a production or manufacturing environment.
• High school diploma or GED required.

Responsibilities

• Perform various technical duties in manufacturing and laboratory settings.
• Ensure compliance with Quality and Regulatory specifications.

Skills

Attention to Detail

Problem Solving

Teamwork

Communication

Time Management

Education

High School Diploma or GED

Tools

SAP

Quality Management Systems (QMS)

Job description

Work Location: St. Louis, Missouri
Shift: No
Department: LS-SC-PMLPC Cell Marque Operations
Hiring Manager: Tara Giebe

This information is for internals only. Please do not share outside of the organization.

Your Role

Under direct supervision at our Spruce Site, the Production Lab Tech II performs various technical-level duties in the areas of manufacturing, filling, labeling, packing, shipping, and other duties as assigned in a laboratory/manufacturing environment adhering to standard operating procedures involving basic laboratory techniques, calculations, materials measurements, operation of laboratory equipment and record keeping as necessary. Daily tasks may include planning, troubleshooting SAP, helping with Dev/CAPA investigations, routine laboratory maintenance, or housekeeping. Specific responsibilities include:

• Perform area clearance tasks and maintaining separation of product
• Perform standard and new operating procedures
• Collect and record data on documents and batch records where required
• Utilize computer hardware and software for data entry and record keeping where required
• Ensure compliance with all Quality and Regulatory specifications
• Support process improvement through identification and reporting of areas needing improvement and assisting in improvement projects
• Effectively utilize Quality Management Systems (QMS) and other applicable databases
• Familiarity with and proper use of safety equipment and Personal Protective Equipment (PPE)
• Demonstrate attention to detail and complete work according to daily schedule
• Verify data against standard
• Print and apply product labels based on established production plan
• Fill and package product based on an established production plan
• Fill and package product using standardized techniques and practices
• Stock inventory as necessary
• Demonstrated ability to learn and understand safe laboratory practices
• Support 6S programs to maintain a Lean work environment
• Work occasional overtime and weekends as needed to meet production requirements
• Comply with applicable established cGMP, FDA, OSHA, EPA, and Quality System regulations
• Report all deviations from established procedural documents to the appropriate supervisor/managers
• Additional duties as defined by management and business needs
• Participate in production failure investigations
• Attend and participate in scheduled meetings
• Compose emails to groups according to good business writing standards
• Effectively present DMS Board to management and coworkers
• Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual
• Other duties as assigned or required to support the business
• Customer service: Respond promptly to internal customer needs from other departments
• Professionalism: Approach others in a tactful manner, react well under pressure, treat others with respect and consideration, present a professional image in all business matters
• Productivity: Meet productivity standards, strive to increase productivity without sacrificing quality and safety
• Quality: Look for ways to improve and promote quality, demonstrate accuracy and thoroughness
• Continuous improvement: Regularly submit suggestions for improvement (SFIs)
• Ethics: Treat people with respect, keep commitments, work with integrity and ethics, uphold organizational values
• Diversity: Promote a harassment-free environment, show respect and sensitivity for cultural differences
• Teamwork: Exhibit objectivity and openness to others' views, give and welcome feedback, support others' efforts to succeed
• Problem solving: Identify and resolve problems in a timely manner, develop alternative solutions
• Safety: Observe safety procedures, report potentially unsafe conditions, use equipment and materials properly and according to usage guidelines
• Planning/organizing: Manage time and priorities work to meet deadlines, effectively multitask with various interruptions
• Judgment: Make timely decisions, exhibit sound and accurate judgment

Who You Are

Minimum Qualifications:

• High school diploma or GED required
• 1+ years of experience within a production or manufacturing environment

Preferred Qualifications:

• Working knowledge of SAP, SAPNEXT, or other ERP systems
• Knowledge of GMP facility, FDA QSRs, and ISO 13485
• Experience in an FDA regulated biotechnology or pharmaceutical environment
• The ability to learn, understand, and carry out safe laboratory practices
• Proficiency with Quality Management Systems (QMS)
• Knowledge of the metric systems
• Ability to communicate effectively with all levels within the organization and outside contacts

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.