Katalyst CRO
Quality Control and Packaging Specialist
Responsible for operating and managing high-speed pharmaceutical packaging lines in compliance with SOPs, cGMPs, and safety standards. Ensures product quality, accurate documentation, and efficient line performance while supporting team goals and continuous improvement.
Responsibilities
Operate and monitor manual/automated equipment for assembly, filling, labeling, and packaging.
Perform line set‑ups, changeovers, and clearances per SOPs and GMPs.
Conduct in-process inspections, verify components, and reconcile product counts.
Maintain cleanrooms and equipment following cGMP and 5S standards.
Accurately complete batch records, logbooks, and documentation.
Accept/reject products based on quality standards.
Collaborate with maintenance and team members to resolve issues and improve processes.
Participate in training, meetings, and team development activities.
Regulatory Compliance
Adhere to FDA, ISO 13485, EC MDD, CMDR, OSHA, EPA, and other global regulatory standards.
Support environmental, health, and safety initiatives.
Requirements
High School diploma or equivalent.
1+ year experience in high-speed manufacturing (pharma preferred).
Familiarity with GMP environments and aseptic production.
Basic Microsoft Office and SAP knowledge.
Skills & Physical Requirements
Strong attention to detail, math skills, and manual dexterity.
Effective communication and teamwork.
Ability to lift (up to 40 lbs for men, 35 lbs for women), stand, bend, and stretch.
Willingness to work any shift (up to 12 hours) and comply with gowning protocols.
Time Allocation
50%: Equipment operation and packaging.
30%: Documentation and compliance.
20%: Team collaboration and process improvement.
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Responsibilities
Operate and monitor manual/automated equipment for assembly, filling, labeling, and packaging.
Perform line set‑ups, changeovers, and clearances per SOPs and GMPs.
Conduct in-process inspections, verify components, and reconcile product counts.
Maintain cleanrooms and equipment following cGMP and 5S standards.
Accurately complete batch records, logbooks, and documentation.
Accept/reject products based on quality standards.
Collaborate with maintenance and team members to resolve issues and improve processes.
Participate in training, meetings, and team development activities.
Regulatory Compliance
Adhere to FDA, ISO 13485, EC MDD, CMDR, OSHA, EPA, and other global regulatory standards.
Support environmental, health, and safety initiatives.
Requirements
High School diploma or equivalent.
1+ year experience in high-speed manufacturing (pharma preferred).
Familiarity with GMP environments and aseptic production.
Basic Microsoft Office and SAP knowledge.
Skills & Physical Requirements
Strong attention to detail, math skills, and manual dexterity.
Effective communication and teamwork.
Ability to lift (up to 40 lbs for men, 35 lbs for women), stand, bend, and stretch.
Willingness to work any shift (up to 12 hours) and comply with gowning protocols.
Time Allocation
50%: Equipment operation and packaging.
30%: Documentation and compliance.
20%: Team collaboration and process improvement.
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