Quality Floor Specialist (Nights)

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. These activities may include reviewing documents and data, conducting floor audits and process inspections, consulting on quality and compliance issues, and performing quality and compliance training as needed. The position requires execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile. 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. Conduct complex quality floor inspections and process walkthroughs. Provide real-time quality guidance to Manufacturing personnel during active operations. Independently identify, document, and elevate 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. Identify and implement quality improvement initiatives. Assists 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. Perform essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position. 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. Candidates need to be competent with IT systems, and Microsoft Office including Outlook, PowerPoint, Word and Excel. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. 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. Travel Requirement Up to 5% travel required. Other Qualifications, Skills and Abilities May be required to respond to operational needs outside of core working hours. Diversity and Inclusion Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law. #J-18808-Ljbffr Sterling Pharma Solutions