POSITION OVERVIEW

We are seeking a Quality Assurance Supervisor to oversee all QA activities during the 2nd shift in our packaging operations. This role ensures product quality and GMP compliance through supervision of QA associates and execution of quality inspections, documentation reviews, and continuous improvement initiatives.

EDUCATION QUALIFICATIONS

The ideal candidate’s minimum qualifications will include:

• A bachelor’s degree (BS or BA) in Chemistry or related technical/physical science from an accredited college/university is required.
• A master’s degree in a field to study relevant to the position is preferred.
• 5 – 7 years in Pharmaceuticals QA, with a focus on packaging operations.

EXPERIENCE

• Lead, manage, and provide guidance to QA inspectors in 2nd shift.
• Oversee and perform QA functions: Incoming, Dispensing, In-Process, and Final Inspections.
• Promote a safety-first and compliance-driven culture on the packaging floor.
• Monitor QA metrics and support ongoing process improvements.
• Ensure proper execution and closure of CAPAs, Deviations, and Change Controls (TrackWise).
• Conduct routine shop floor quality rounds to ensure GMP compliance.
• Participate in SOP development, validation, and investigation activities.
• Provide training, coaching, and performance reviews for QA inspectors.
• Approve leaves, manage attendance (via ADP), and foster cross-training.
• Review batch records and pre-check documentation for completeness, accuracy, and GMP compliance prior to production and packaging activities.
• Sign and authorize work orders to ensure readiness and compliance before execution.
• Review and approve protocols related to packaging processes, validations, and quality initiatives in alignment with regulatory and internal standards.

SKILLS/ COMPETENCIES

• Strong computer skills including Microsoft Office Tools, Track Wise, Oracle and SAP.
• Proficiently speak English as a first or second language.
• Proficiently communicate and understand (read and write) scientific / regulatory based ‘workâ€� in English.
• Bi-lingual in the Spanish language (speaking, writing, interoperating and translation) is preferred.
• Have excellent organization, learning and teaching skills required to work in teams.
• Ability to understand and analyze complex data sets.
• Strong desire towards continuous improvement.

PHYSICAL REQUIREMENTS

• This role works in a current Good Manufacturing Practice (cGMP) office, laboratory and manufacturing environment, where personal protective equipment (PPE) may be required, which may include uniforms, lab coats, safety glasses, respiratory PPE, hearing protection, etc.
• Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility may be required.
• Sitting at a desk and/or working at a computer or other “screenâ€� 75% or greater of an 8-hour period may be required.
• Up to 60-70% travel may be required.
• Relocation negotiable.
• Must be willing to work long hours and some weekends based on a relevant business need, if required.

The scope of this focus will include but is not limited to:

• Ensure that tools are provided, and concerns are escalated, as appropriate.
• Ensure that the department teams are working in a safe way and following all safety rules and procedures.
• Ensure compliance to all data integrity and cGMP practices, procedures, and expectations.
• Other specific duties and responsibilities as assigned.