Associate Specialist, Operations
Merck
1 month ago
On-site
De Soto, KS
Operations
Associate Specialist, Downstream Processing (Production Operations)
Responsibilities
- Act as a Subject Matter Expert (SME) supporting continuous improvement, problem solving, deviations, and change management.
- Model leadership/inclusive behaviors; coach and support team skills development and performance feedback; provide task-based training.
- Demonstrate EHS and Quality compliance mindset; follow safe operating instructions; ensure correct tools/PPE are available and used; address defects/hazards immediately; report accidents/incidents/near misses within 24 hours and support investigations and CAPA.
- Complete Quality compliance tasks related to Deviation, CAPA, and Change Control; apply cGMP and good documentation practices (RFT) and coach others; serve as Change Manager/stakeholder for production change activities; support update/review/approval of GMP documents (e.g., SOPs, Master Docs, Qualification Protocols, new product/product transfer documentation).
- Support schedule adherence; collaborate with Site Operations stakeholders (BTS, Engineering, Quality, R&D); lead by example in continuous improvement; support project portfolio/improvement initiatives; apply Lean Six Sigma, PM, and Change Management tools; investigate and solve operational issues; use data-driven decision-making and visualize progress/results; identify financial savings opportunities.
Qualifications
- Required: High School Diploma + 3+ years in pharmaceutical manufacturing.
- Preferred: BS in relevant scientific discipline + 1+ year in pharmaceutical manufacturing.
Required Skills
- GMP compliance; cGMP/documentation; change management/request management; investigation procedures; process control/production operations & scheduling; detail-oriented; driving continuous improvement; liquid chromatography (LC); autoclaving; buffer/media preparation; cell culture/fermentation process development; filtration equipment; adverse event reporting.
Benefits (if applicable)
- Annual bonus and long-term incentive (as applicable); comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, sick/compassionate time).
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is listed on the posting.
Responsibilities
- Act as a Subject Matter Expert (SME) supporting continuous improvement, problem solving, deviations, and change management.
- Model leadership/inclusive behaviors; coach and support team skills development and performance feedback; provide task-based training.
- Demonstrate EHS and Quality compliance mindset; follow safe operating instructions; ensure correct tools/PPE are available and used; address defects/hazards immediately; report accidents/incidents/near misses within 24 hours and support investigations and CAPA.
- Complete Quality compliance tasks related to Deviation, CAPA, and Change Control; apply cGMP and good documentation practices (RFT) and coach others; serve as Change Manager/stakeholder for production change activities; support update/review/approval of GMP documents (e.g., SOPs, Master Docs, Qualification Protocols, new product/product transfer documentation).
- Support schedule adherence; collaborate with Site Operations stakeholders (BTS, Engineering, Quality, R&D); lead by example in continuous improvement; support project portfolio/improvement initiatives; apply Lean Six Sigma, PM, and Change Management tools; investigate and solve operational issues; use data-driven decision-making and visualize progress/results; identify financial savings opportunities.
Qualifications
- Required: High School Diploma + 3+ years in pharmaceutical manufacturing.
- Preferred: BS in relevant scientific discipline + 1+ year in pharmaceutical manufacturing.
Required Skills
- GMP compliance; cGMP/documentation; change management/request management; investigation procedures; process control/production operations & scheduling; detail-oriented; driving continuous improvement; liquid chromatography (LC); autoclaving; buffer/media preparation; cell culture/fermentation process development; filtration equipment; adverse event reporting.
Benefits (if applicable)
- Annual bonus and long-term incentive (as applicable); comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, sick/compassionate time).
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is listed on the posting.