Quality Floor Specialist (Nights) - Sterling Pharma Solutions

Quality Floor Specialist (Nights) - Sterling Pharma Solutions at Sterling Pharma Solutions Quality Floor Specialist (Nights) - Sterling Pharma Solutions at Sterling Pharma Solutions in Germantown, Wisconsin Posted in 13 days ago.

Job Description:

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 processes 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. 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. An individual in this position must be able to successfully perform the 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. Please note 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. Why Consider Sterling? Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented 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 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.