Quality Floor Specialist (Days)

Desirable day shift, only working 14 days/month!

About the Role

The Quality Floor Specialist provides direct Quality Assurance presence in production areas and serves as a quality decision maker during manufacturing operations to ensure GMP-compliant operations. This role promotes a culture of compliance, ownership, and quality awareness on the production floor. The Quality Floor Specialist is accountable for driving results in a fast-paced environment by effectively performing activities of some variety and complexity to ensure quality and compliance with applicable regulatory requirements.

Responsibilities

• Perform on-the-floor quality review of log books, cleaning records, batch records, and analytical data.
• Conduct complex quality floor inspections and process walkthroughs.
• Provide real-time quality guidance to Manufacturing personnel during active operations.
• Independently identify, document, and escalate observed quality or compliance concerns.
• Proactively identify emerging risks and require timely corrective actions prior to batch completion when possible.
• Perform line and area clearance in coordination with manufacturing personnel.
• Exercise quality authority to approve, restrict, or halt activities when quality or compliance risks are identified.
• Provide training in quality and compliance topics in areas of expertise.
• Identify and implement quality improvement initiatives.
• Assist with development/writing of SOPs or other quality documents and/or reports as needed.
• Maintain accurate files and records.
• Serve as an effective member of the Quality team and may serve as a mentor to other employees in the area of expertise.
• Comply with company policies and SOPs.
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements.

Requirements

• Bachelor's degree in Chemistry, Biology, or related field with 3+ years GMP-related experience, or
• Master's degree in related field with 1+ years related experience, or equivalent educational and work experience.
• Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
• Ability to apply regulations and procedures to make real-time quality decisions.
• Demonstrated risk awareness in fast-paced manufacturing environment.
• Proven ability to act independently and exercise quality authority.
• Proficiency in SAP and electronic quality systems.
• Excellent written and oral communication skills for internal and client interactions.
• Good math skills.
• Ability to be trained and to mentor.
• Ability to interact well with employees at all levels.
• Proficiency with Microsoft Office products (Outlook, PowerPoint, Word, Excel).
• May be required to respond to operational needs outside of core working hours.
• Up to 5% travel required.

Schedule

This position operates on a 2-2-3 schedule of 12-hour day shifts (6:00 AM to 6:30 PM), which means you work only 14 days each month. Enjoy every other weekend off and long stretches of time for rest, personal projects, or travel. It's an excellent fit for individuals who value work-life balance with extended time off built into their routine.

About the Company

Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services. We are a fast-growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and way of working set us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.