Quality Floor Specialist (Nights)

Summary of 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.

Shift

This position operates on a 2-2-3 schedule of 12-hour night shifts (6:00 PM to 6:30 AM), which means you work only 14 days each month PLUS earning an additional incentive on all hours worked! 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.

Essential Functions

• Perform on-the-floor quality review of log books, cleaning records, batch records, and analytical data.
• Conducts 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.
• Performs 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.
• Ability to identify and implement quality improvement initiatives.
• Assists with development/writing of SOPs or other quality documents and/or reports as needed.
• Maintains accurate files and records.
• Serves as an effective member of the Quality team and may serve as a mentor to other employees in the area of expertise.
• Complies with company polices and SOPs.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Key Competencies

• 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.

Education and Experience

• 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.

Certifications, Business Licenses, Registrations

• None.

Other Qualifications, Skills and Abilities

• May be required to respond to operational needs outside of core working hours.

Why Consider Sterling?

At Sterling Pharma Solutions, we are committed to creating an inclusive environment for all employees. 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 our way of working is what really sets 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.