Quality Specialist - Drug Packaging bei Outlook Group, LLC

Outlook Group is seeking a Quality Specialist in Drug Packaging to be part of our team. This position ensures that all products are manufactured, packaged, and labeled according to strict Good Manufacturing Practices (GMP) and other regulatory standards. This specialist role is critical for ensuring product safety, efficacy, and accurate labeling for distribution and key to helping Outlook Group ensure service excellence. 

Outlook Group is a printer and converter of labels, flexible packaging and folding cartons. Our integrated packaging solutions offer diverse, innovative and sustainable packaging capabilities. Our multiple facilities total nearly 500,000 square feet of certified manufacturing, warehouse, fulfillment and R&D space.

Responsibilities:

• GMP compliance: Enforces adherence to Current Good Manufacturing Practice (cGMP) regulations throughout the packaging process, as mandated by the Food and Drug Administration (FDA). This includes ensuring all Standard Operating Procedures (SOPs) are followed and any deviations are thoroughly investigated.
• Program oversight: Leads and trains quality control (QC) and packaging personnel on quality standards and procedures. Responsible for scheduling tasks, monitoring performance, and fostering a culture of quality. This position does not have any direct reports.
• Documentation and record-keeping: Manages and reviews all GMP documentation, including batch production records, in-process testing results, and batch release paperwork. This ensures complete traceability for each product lot.
• Quality control activities: Oversees all quality control tasks on the packaging line, such as:
  • Inspecting incoming packaging materials.
  • Monitoring in-process controls and environmental conditions.
  • Conducting final inspections of packaged drug products.
  • Ensuring correct labeling, batch numbering, and expiration dating.
• Deviation and CAPA management: Investigates and documents any non-conforming materials or quality incidents (deviations) on the packaging line. Responsible for developing and implementing Corrective and Preventive Actions (CAPA).
• Line clearance: Conducts thorough line clearances to prevent product mix-ups when changing between different products or batches.
• Audits and inspections: Prepares for and participates in internal and external regulatory audits by agencies like the FDA.

Within a pharmaceutical context, the specialist oversees both quality control and quality assurance activities.

• Quality control (QC): This is a reactive process of detecting and fixing quality issues. QC activities are focused on inspections and testing to verify that a product meets quality standards.
• Quality assurance (QA): This is a proactive process that aims to prevent defects. QA involves setting up the overall quality system, writing SOPs, and training personnel to ensure that the process itself minimizes errors. The quality specialist bridges these two functions by both executing QC inspections and enforcing the broader QA plan.

Qualifications:

• Bachelor’s Degree in a relevant field such as science, engineering, or a related discipline preferred.
• Three to five years of progressive experience in a GMP-regulated manufacturing environment.
• Technical expertise: Knowledge of manufacturing methods, quality systems, and statistical quality control.
• Communication: Strong verbal and written skills for reporting, training, and collaborating across departments.
• Attention to detail: A meticulous and detail-oriented approach to monitoring processes and documentation.
• Excellent leadership and decision-making skills.

What we offer you:

• Health, Dental, Vision, Life and Disability Insurance
• 401K with company match
• PTO
• Education reimbursement
• Career development

If this sounds like the opportunity you’ve been looking for, apply today!