The Ritedose jobs in Columbia, SC - 21 jobs

Apply Description Corporate Statement Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. Job Summary The BFS Line Technician I plays' a vital role in ensuring the efficient and compliant operation of Blow-Fill-Seal machinery used in the production of sterile pharmaceutical products. This position is responsible for operating, monitoring, and maintaining BFS downstream equipment, ensuring product quality, and adhering to all Current Good Manufacturing Practices (CGMP), safety regulations, and company protocols. Equipment Operation Set up and operate BFS downstream machinery according to established SOPs and Batch Records. Monitor machine performance and production output to ensure efficiency and compliance. Perform routine adjustments and troubleshoot minor issues to maintain continuous operation. Reset equipment alarms and ensure all materials are properly staged for production. Quality Assurance & Documentation Accurately complete Batch Records, logbooks, setup sheets, and other documentation in a timely manner. Identify and escalate product quality or equipment concerns to supervisors. Ensure all work is completed in strict adherence to CGMP standards. Support investigations into deviations and assist in implementing corrective actions. · Review MBRs and log book for accuracy and GMP standard. Safety & Housekeeping Adhere to all safety protocols and wear proper personal protective equipment (PPE) when needed. Maintain cleanroom and production areas to meet internal and regulatory cleanliness standards. Perform and document routine housekeeping and participate in facility inspections. Teamwork & Communication Collaborate with Quality, Maintenance, Packaging, and other cross-functional teams to ensure smooth operations. Participate in training sessions to build technical and procedural knowledge. Provide guidance and training to new or junior operators as needed. Training & Development Complete required training and maintain certifications in alignment with company and regulatory requirements. Stay updated on procedural changes and complete retraining within designated timeframes. Provide mentorship and training to junior machine operators and new team members in equipment operation, safety protocols, and industry best practices. Other Duties Perform additional responsibilities as assigned to support production goals and departmental needs. Knowledge, Skills, & Abilities Basic mechanical aptitude and understanding of automated manufacturing equipment. Ability to interpret SOPs, technical documents, and Batch Records. Strong attention to detail with a focus on accuracy and quality. Effective verbal and written communication skills. Team-oriented with the ability to work independently when required. Flexibility to work shifts, weekends, or overtime based on production needs. Available for 12-hour shifts (0600-1830 or 1800-0630), including nights, weekends, or holidays as needed. Education & Experience High school diploma or GED required. Technical certifications or training in manufacturing or mechanical systems preferred. Previous experience in pharmaceutical or sterile manufacturing environments is a plus. Familiarity with BFS technology is highly desirable. Work Conditions & Requirements Must be able to lift up to 50 lbs and stand for prolonged periods in a cleanroom environment. Must wear all required PPE, including gloves, gowns, masks, and goggles. Available for 12-hour shifts (0600-1830 or 1800-0630), including nights, weekends, or holidays as needed. Why Join Nephron? Cutting-edge manufacturing environment Commitment to safety, quality, and innovation Growth and development opportunities Team-driven culture with a mission to make affordable medication accessible to all EEO Statement Nephron Pharmaceuticals is proud to be an equal opportunity employer. We are committed to fostering an inclusive workplace where all individuals are respected and valued regardless of race, color, religion, gender, sexual orientation, age, national origin, disability, veteran status, marital status, genetic information, or any other legally protected status.

Apply Description Corporate Statement: Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. ____ Job Purpose: Ø Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations. Ø Ensures the accuracy and completeness of batch records. Ø Performs other duties as assigned or apparent. ____ Essential Duties and Responsibilities: Ø Review Batch Records and applicable documentation to ensure complete, thorough and accurate data. Ø Responsible for ensuring a high level of employee accountability and performance. Ø Maintains quality assurance documentation including shift pass downs. Ø Keep QA work station clean and orderly. Ø Perform packaging line clearances. Ø Pull Retain, Stability, and Lab samples. Ø Perform or verify Quality Finished Product Attribute Inspections. Ø Perform AQL Calculations. Ø Verify component Exhibits Ø Verify all documents are present within the batch record. Ø Support validation and manufacturing studies, including special sampling and testing. Ø Communicate with Management any quality issues identified with product Supplemental Functions: Ø Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations. Ø Assist with development of solutions for chronic problems within quality assurance Ø Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management. Ø Adherence to cGMPs is required at all times. All personnel own the quality of the product delivered and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Ø Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. Ø Assist in other activities (as needed) for Quality Assurance management. ____ Job Specifications and Qualifications: Skills: Detail oriented. Technical writing skills required. Good written, oral and comprehensive communication skills. Operating computer and relevant software;. Must be proficient in MS Word, Excel, and PowerPoint; Abilities: The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication; and provides participation, learning, feedback and recognition. The ability to effectively manage one's self, demonstrates integrity, be productive under pressure, and achieve development goals. Ability to handle contending priorities and managing partner expectations The ability and willingness to change direction and focus to meet shifting organizational and business demands. Assist in other activities (as needed) for Quality Operations management. Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law. Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Education/Experience: Minimum of High School Diploma or GED required. ____ Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 25 1bs.), standing, sitting and walking throughout the facility. _____ The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace.

Salary Description $23.00/Hr

Apply Description Job Purpose: Quality Operations Clean Room Technicians Tier I are to monitor filling operations in compliance with company policies and Standard Operating Procedures, as well as FDA and cGMP regulations. Qualified individuals will be responsible to ensure the accuracy and completeness of batch records, and perform personnel monitoring, general operations filling in manual hoods, and other duties as necessary. Technicians will assist with additional work duties or responsibilities as evident or required. Essential Duties and Responsibilities: · Monitors aseptic techniques of personnel within the clean room. · Monitor Outsourcing filling operations within the clean rooms. · Verifies syringe filling rejects of Outsourcing products and performs quality attribute inspections as needed. · Maintains quality assurance documentation. · Review/sign appropriate sections designated for Pharmacist/QA designee signatures within the batch records. · Promotes teamwork both within the QA Team and other departments. · Monitors all filling areas and personnel for adherence to all cGMP, SOP's and safety regulations. · Keep line and work station clean and orderly to ensure no product line contamination. · Perform line clearance including equipment, components and label verification. · Perform room releases for filling rooms for Outsourcing areas. · Communicate quality - related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor/Management. · Review all completed production batch record documentation to ensure completion and compliance. · Reviewing Logbooks for GDP and accuracy. · Performs general operation QA functions for manual filling processes. · Ability to perform personnel monitoring within the clean room. · Trained and authorized to enter samples into LabVantage. Supplemental Functions: · Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations. · Assist with development of solutions for chronic problems within quality assurance · Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management. · Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. · Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. · Assist in other activities (as needed) for Quality Assurance management. Knowledge & Skills: · Detail oriented. · Good computer skills in MS Outlook, MS Word, MS Excel, Internet, Email and basic typing skills. · Good visual acuity and observation skills. · Good written, oral and comprehensive communication skills. · Able to handle diversity of projects. · Specific expertise, skills and knowledge within quality assurance gained through education and experience. · A board perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. · The ability and willingness to change direction and focus to meet shifting organizational and business demands. · The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. · The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. · Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary. Education/Experience: · High School Diploma or GED · Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred. Working Conditions / Physical Requirements: · Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25lbs), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing and hearing.

Apply Description Microbiology Environmental Monitoring Technician I Corporate Statement Nephron Pharmaceuticals Corporation is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. Position Summary: The Microbiology Environmental Monitoring (EM) Technician I is an entry level position that performs air quality, environmental, and personnel monitoring throughout the facility. EM Technician I collect samples of water for injection (WFI) and performs enumeration. EM Technician I assist with Gown Certification Training and additional responsibilities delegated by EM Leads. EM Technician I must uphold cGMP and Nephron's core beliefs. Page 1 of 3 Primary Accountabilities Perform daily activities to monitor environment, air quality, and personnel samples in production area. • Enumerate samples. • Execute data entry and/or form completion. • Complete sampling program for facility WFI system. • Assist Gown Certification Training. • Utilize MODA per procedure to record and track environmental and personnel monitoring samples. NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager. Knowledge, Skills, & Abilities • High School Diploma or Bachelor's degree with a science background preferred. • Experience in pharmaceutical industry or clinical background with cGMP preferred. • Lab experience preferred. • Must be open to receive training in other areas and accept changes in order to achieve department demands. • Must have strong organizational and time management skills, and must be able to multitask. • The ability to meet deadlines. • The ability to adapt to department needs. • The ability to effectively work independently, demonstrate integrity, and perform under pressure. • The ability to spend at least 6 hours a shift on your feet. • Salary Range: Based on experience • Work Shift: 12 hour rotating shift EEO Statement: Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace.

Apply Description The Manager of Financial Planning and Analysis (FP&A) will lead our financial modeling, forecasting, and analysis functions. They will have a deep understanding of financial strategy, exceptional attention to detail, and proven experience in credit modeling, restructuring, or FP&A within a professional services or consulting firm environment. This role requires a blend of strategic thinking, hands-on financial analysis, and teamwork. Essential Duties and Responsibilities: Ø Strategic Financial Leadership: o Develop and implement financial strategies that align with long-term business objectives. o Analyze operational challenges and recommend solutions to optimize financial performance. Ø Operational Efficiency: o Identify inefficiencies in operational processes and recommend cost-saving measures. o Develop actionable insights to improve overall financial health and organizational efficiency. Ø Teamwork: o Foster a collaborative, team-oriented culture that encourages innovation and high performance. Supplemental Functions: Ø Performs other similar duties as required. ____ Job Specifications and Qualifications: Ø Financial Analysis and Modeling: o Build, maintain, and enhance complex financial models, including: § 13-week cash flow forecasting. § Company annual and long-range financial model. § Covenant compliance analysis. § Profitability and liquidity assessment. o Perform sensitivity analyses to evaluate the impact of various financial scenarios. o Analyze financial statements to identify trends, risks, and opportunities for improvement. o Collaborate with stakeholders to understand and refine model assumptions. o Maintain expertise in asset-based lending environments and borrowing base certificates. Education/Experience: Bachelor's degree in Finance or a related field, with five (5+) years of experience of progressive finance experience. (Master's degree preferred) Licensing and Certifications: Certified Public Accountant (CPA) optional Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 20 1bs.), standing, sitting and walking throughout the facility.

Apply Description Corporate Statement: Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. Job Purpose: The Utility Maintenance Manager is responsible for the routine and preventive maintenance of critical utility systems supporting pharmaceutical manufacturing. The role ensures all utility equipment operates reliably, efficiently, and in compliance with GMP standards and regulatory requirements. Essential Duties and Responsibilities: Ø Perform preventive and corrective maintenance on utility systems including: Ø HVAC and cleanroom environmental systems Ø Purified Water (PW) / Water for Injection (WFI) systems Ø Clean steam generators and distribution Ø Compressed air and gas systems (Nitrogen, CO2, etc.) Ø Boilers and chillers Ø Conduct routine inspections, monitoring, and performance checks on utility systems. Ø Maintain accurate maintenance logs, calibration records, and ensure data integrity in all documentation. Ø Support utility system qualification/validation activities (IQ, OQ, PQ). Ø Follow established Standard Operating Procedures (SOPs) and Good Documentation Practices (GDP). Ø Assist with deviation investigations, change control, and CAPA implementation related to utility systems. Ø Work collaboratively with manufacturing, quality assurance, and validation teams to support production needs. Ø Ensure compliance with cGMP, FDA, EMA, and other regulatory guidelines Ø Identify and recommend improvements to increase utility system reliability and performance. Ø Participate in training, internal audits, and cross-functional team initiatives. Ø All other necessary duties required of the position or requested by Management. Supplemental Functions: Ø Performs other similar duties as required. Job Specifications and Qualifications: Technical Skills: Ø Proficiency in reading P&IDs, electrical schematics, and utility system layouts. Ø Experience with CMMS (Computerized Maintenance Management Systems). Ø Knowledge of clean utility system operation and troubleshooting. Abilities: Ø Ability to handle contending priorities and managing partner expectations. Ø Strong troubleshooting and mechanical aptitude. Ø Attention to detail and documentation accuracy. Ø Good communication and teamwork skills. Ø Ability to work independently and prioritize tasks under pressure. Education/Experience: Ø Diploma or degree in Mechanical, Electrical, or Industrial Engineering, or relevant technical field. Ø 2-5 years of experience in pharmaceutical or regulated utility system maintenance. Ø Strong understanding of GMP and pharmaceutical manufacturing environments. Licensing and Certifications: Ø HVAC Certification, Boiler License, or Water System Operation certifications. Ø GMP/GDP compliance training. Working Conditions / Physical Requirements: Ø This position requires bending, typing, lifting (up to 20 1bs.), standing, sitting and walking throughout the facility. The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace.

Apply Description Job Purpose: Provide strategic and operational leadership for Quality Operations supporting aseptic manufacturing, including Blow-Fill-Seal (BFS) and conventional sterile filling processes. Ensure full compliance with FDA 503B regulations, cGMP requirements, and applicable regulatory standards by establishing, maintaining, and continuously improving robust Quality Systems. Oversee quality oversight of facilities, utilities, equipment, and environmental monitoring programs to ensure sterility assurance and a sustained state of control. Lead and develop a high-performing Quality Operations organization, fostering a strong culture of quality, data integrity, inspection readiness, and continuous improvement. Partner cross-functionally with Manufacturing, Engineering, and Supply Chain to enable compliant, efficient operations, ensure uninterrupted supply, and serve as the primary Quality representative during regulatory inspections and audits. Essential Duties and Responsibilities: · Provide Quality Operations leadership for aseptic manufacturing, including Blow-Fill-Seal (BFS), conventional sterile filling, visual inspection, and secondary packaging operations. · Ensure compliance with FDA 503B regulations, cGMP requirements, and data integrity standards across all manufacturing and quality activities. · Own and maintain site Quality Systems, including deviations, investigations, CAPA, change control, complaints, and document control. · Provide Quality oversight and approval for batch record review, product disposition, validation activities, and aseptic process controls. · Support sterility assurance programs, including environmental and utilities monitoring, contamination control strategy, and aseptic process simulations. · Lead inspection readiness and serve as the primary Quality representative during FDA, customer, and regulatory audits. · Partner with Manufacturing, Engineering, and Technical Services to support equipment qualification, process changes, capital projects, and technology transfers impacting filling, inspection, and packaging operations. · Lead, develop, and mentor the Quality Operations team while driving a strong culture of quality, compliance, and continuous improvement. · Oversee Quality review and approval of facilities, utilities, and equipment qualification, calibration, maintenance, and lifecycle management activities. · Establish and monitor Quality metrics and KPIs to assess performance, identify trends, and drive continuous improvement initiatives. · Lead, coach, and develop the Quality Operations team, ensuring appropriate staffing, training, and succession planning. · Ensure effective supplier quality management, including qualification, audits, and oversight of critical vendors and contract service providers. · Review and approve procedures, protocols, reports, and quality agreements to ensure regulatory compliance and operational alignment. · Drive a culture of quality, accountability, and continuous improvement across the site. · Escalate quality risks appropriately and ensure timely, effective mitigation to protect patient safety and product quality. Knowledge & Skills: Comprehensive understanding of FDA regulatory frameworks covering both 503B Outsourcing Facility requirements and cGMP operations, including 21 CFR Parts 210/211 and applicable guidance documents. Strong expertise in sterility assurance, aseptic processing, environmental monitoring, and contamination control strategies within sterile manufacturing, visual inspection, and secondary packaging. Experience leading FDA inspections, regulatory audits, and customer audits, with strong inspection readiness and response capabilities. Proven ability to apply quality risk management principles and data-driven decision-making to ensure product quality and patient safety. Strong leadership, coaching, and organizational development skills, with the ability to build and sustain high-performing Quality teams. Effective cross-functional collaboration skills, partnering with Manufacturing, Engineering, Technical Services, and Supply Chain. Experience with change control, deviation investigations, and CAPA systems within a GMP-regulated manufacturing environment. Experience with quality approval for process validation and equipment qualification (IQ/OQ/PQ), media fills, cleaning validation, and lifecycle process management. Proficiency with quality metrics, KPIs, and continuous improvement methodologies to drive compliance and operational excellence. Strong leadership capabilities with experience coaching and developing high-performing teams across operations and quality. Prior experience supporting regulatory inspections (FDA, state board of pharmacy, or third-party audits). Must be detailed oriented and have excellent organizational skills. Must have excellent communication and technical writing skills. Ability to drive continuous improvement initiatives while maintaining regulatory compliance and quality standards. Strong organizational skills with the ability to manage multiple priorities in a fast-paced, regulated environment. Education/Experience: Bachelor's degree in Engineering, Life Sciences, Pharmacy, Chemistry, or a related scientific/technical discipline required. Minimum of 10+ years of progressive experience in Quality Assurance / Quality Operations within a cGMP-regulated pharmaceutical or biotechnology environment. At least 5+ years of leadership experience managing Quality teams supporting sterile manufacturing operations. Hands-on experience with aseptic processing, visual inspection, and secondary packaging. Proven experience overseeing Quality Systems such as deviations, investigations, CAPA, change control, and document control. Experience supporting equipment qualification, process validation, environmental monitoring, and sterility assurance programs. Strong background in inspection readiness, audit management, and regulatory interactions. Hands-on experience supporting FDA inspections, regulatory audits, and responses to inspection observations (e.g., FDA Form 483). Strong background in operational excellence, continuous improvement, and performance management. Demonstrated ability to lead cross-functional teams while maintaining Quality unit independence and regulatory compliance. Salary Range: Based on experience Working Conditions / Physical Requirements: • Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing.

Apply Description Job Purpose: Commodities Technician will perform all duties as assigned or apparent. A Tech will make contact and coordinate with different departments and resources to ensure resin processes are maintained. A Tech will be able to identify all types of resins, regrind, and purge. Techs will clear and separate all waste gaylords with the correct labeling. Finally, Techs will monitor all movement of said commodities. Essential Duties and Responsibilities: · Perform On-the-Job (OJT), group and one-on-one trainings from department personnel. · Contact and coordinate with different departments and resources. · Evaluate and communicate training needs to upper management. · Performs all other duties as assigned or apparent. · Assist and monitor the receipt and release of railcars · Follow up with the Quality department to ensure testing · Maintain company equipment/tools utilized for resin transfers · Complete understanding of how to use the HMI for resin transfer · Check railcars for moisture levels · Assist coordinating quality sampling with the Quality Assurance department upon resin receipt · Monitoring and clearing “knuckle” of all regrind and purge · Assist with movement of wet-waste gaylords from the “knuckle” to the E80 warehouse · Monitoring of the resin regrind room, silo room, and blower house · Maintaining cleanliness of railcar area, blower house, silo room, and resin regrind room. · Grinding, weighing, labeling, and loading of ground resin and purge onto the outbound trailer · Ensuring all resin transfers from start to finish are properly documented and performed using guidance SOPs Supplemental Functions: Copying, filing, and scanning of documents Fork lift operation Regrind troubleshooting Performs other similar duties as required Job Specifications and Qualifications: Knowledge & Skills: MUST PASS DRUG TEST Must speak, write, and read English. A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. The ability and willingness to change direction and focus to meet shifting organizational and business demands in a fast-paced environment. The ability to create and contribute to an environment that values safety, people, encourages trust, teamwork, open communication, and provides participation, learning, feedback and recognition. The ability to effectively manage one self, demonstrate integrity, be productive under pressure, and achieve development goals The ability to manage a multitude of resources and to be accurate and current with data and information. Incumbents are required to wear PPE as assigned by management. Incumbents are required to comply with proper gowning requirements and other non-specified protective equipment as necessary. Incumbents may be required to wear safety glasses, hearing protection, bouffant, and laboratory coats and other non-specified protective equipment as necessary. Salary range: Based on experience Hours of Work: As required by management. Must have schedule flexibility to support all shifts. Education/Experience: High School Diploma or equivalent Previous training in BFS or manufacturing settings experience preferred Computer experience: Excel, Word Working Conditions / Physical Requirements: Position requires lifting (up to 60 lbs.), vision (20/20), bending (waist to floor), climbing (floor to ceiling), reaching (floor to overhead), standing (75%), sitting (5%), walking (20%), gripping, talking and hearing.

Job Title: Quality Operations Secondary Packaging Tier I Reports To: Quality Operations Secondary Packaging Supervisor FLSA Status: Non-Exempt _______________________________________________________________________________________________ Corporate Statement: Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. ____ Job Purpose: Ø Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations. Ø Ensures the accuracy and completeness of batch records. Ø Performs other duties as assigned or apparent. ____ Essential Duties and Responsibilities: Ø Review Batch Records and applicable documentation to ensure complete, thorough and accurate data. Ø Responsible for ensuring a high level of employee accountability and performance. Ø Maintains quality assurance documentation including shift pass downs. Ø Keep QA work station clean and orderly. Ø Perform packaging line clearances. Ø Pull Retain, Stability, and Lab samples. Ø Perform or verify Quality Finished Product Attribute Inspections. Ø Perform AQL Calculations. Ø Verify component Exhibits Ø Verify all documents are present within the batch record. Ø Support validation and manufacturing studies, including special sampling and testing. Ø Communicate with Management any quality issues identified with product Supplemental Functions: Ø Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations. Ø Assist with development of solutions for chronic problems within quality assurance Ø Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management. Ø Adherence to cGMPs is required at all times. All personnel own the quality of the product delivered and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Ø Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. Ø Assist in other activities (as needed) for Quality Assurance management. ____ Job Specifications and Qualifications: Skills: * Detail oriented. * Technical writing skills required. * Good written, oral and comprehensive communication skills. * Operating computer and relevant software;. * Must be proficient in MS Word, Excel, and PowerPoint; Abilities: * The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication; and provides participation, learning, feedback and recognition. * The ability to effectively manage one's self, demonstrates integrity, be productive under pressure, and achieve development goals. * Ability to handle contending priorities and managing partner expectations * The ability and willingness to change direction and focus to meet shifting organizational and business demands. * Assist in other activities (as needed) for Quality Operations management. * Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law. * Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Education/Experience: * Minimum of High School Diploma or GED required. ____ Working Conditions / Physical Requirements: * This position requires bending, typing, lifting (up to 25 1bs.), standing, sitting and walking throughout the facility. _____ The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace.

Job Purpose: Quality Operations Clean Room Technicians Tier I are to monitor filling operations in compliance with company policies and Standard Operating Procedures, as well as FDA and cGMP regulations. Qualified individuals will be responsible to ensure the accuracy and completeness of batch records, and perform personnel monitoring, general operations filling in manual hoods, and other duties as necessary. Technicians will assist with additional work duties or responsibilities as evident or required. Essential Duties and Responsibilities: * Monitors aseptic techniques of personnel within the clean room. * Monitor Outsourcing filling operations within the clean rooms. * Verifies syringe filling rejects of Outsourcing products and performs quality attribute inspections as needed. * Maintains quality assurance documentation. * Review/sign appropriate sections designated for Pharmacist/QA designee signatures within the batch records. * Promotes teamwork both within the QA Team and other departments. * Monitors all filling areas and personnel for adherence to all cGMP, SOP's and safety regulations. * Keep line and work station clean and orderly to ensure no product line contamination. * Perform line clearance including equipment, components and label verification. * Perform room releases for filling rooms for Outsourcing areas. * Communicate quality - related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor/Management. * Review all completed production batch record documentation to ensure completion and compliance. * Reviewing Logbooks for GDP and accuracy. * Performs general operation QA functions for manual filling processes. * Ability to perform personnel monitoring within the clean room. * Trained and authorized to enter samples into LabVantage. Supplemental Functions: * Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations. * Assist with development of solutions for chronic problems within quality assurance * Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management. * Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. * Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. * Assist in other activities (as needed) for Quality Assurance management. Knowledge & Skills: * Detail oriented. * Good computer skills in MS Outlook, MS Word, MS Excel, Internet, Email and basic typing skills. * Good visual acuity and observation skills. * Good written, oral and comprehensive communication skills. * Able to handle diversity of projects. * Specific expertise, skills and knowledge within quality assurance gained through education and experience. * A board perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. * The ability and willingness to change direction and focus to meet shifting organizational and business demands. * The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. * The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. * Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary. Education/Experience: * High School Diploma or GED * Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred. Working Conditions / Physical Requirements: * Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25lbs), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing and hearing.

Microbiology Environmental Monitoring Technician I Corporate Statement Nephron Pharmaceuticals Corporation is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. Position Summary: The Microbiology Environmental Monitoring (EM) Technician I is an entry level position that performs air quality, environmental, and personnel monitoring throughout the facility. EM Technician I collect samples of water for injection (WFI) and performs enumeration. EM Technician I assist with Gown Certification Training and additional responsibilities delegated by EM Leads. EM Technician I must uphold cGMP and Nephron's core beliefs. Page 1 of 3 Primary Accountabilities Perform daily activities to monitor environment, air quality, and personnel samples in production area. * Enumerate samples. * Execute data entry and/or form completion. * Complete sampling program for facility WFI system. * Assist Gown Certification Training. * Utilize MODA per procedure to record and track environmental and personnel monitoring samples. NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager. Knowledge, Skills, & Abilities * High School Diploma or Bachelor's degree with a science background preferred. * Experience in pharmaceutical industry or clinical background with cGMP preferred. * Lab experience preferred. * Must be open to receive training in other areas and accept changes in order to achieve department demands. * Must have strong organizational and time management skills, and must be able to multitask. * The ability to meet deadlines. * The ability to adapt to department needs. * The ability to effectively work independently, demonstrate integrity, and perform under pressure. * The ability to spend at least 6 hours a shift on your feet. * Salary Range: Based on experience * Work Shift: 12 hour rotating shift EEO Statement: Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace.

Salary Description Hourly: $30.00/hr - $40.00/hr based on experience

Apply Description Job Purpose: The Sterile Filling Technician is responsible for performing aseptic filling and related sterile operations within a 503B outsourcing pharmaceutical manufacturing facility. This role ensures products are prepared, filled, and packaged in compliance with FDA 503B regulations, cGMP standards, and company SOPs to ensure product quality and patient safety. __________________________________________________________________________________________ Essential Duties and Responsibilities: Sterile Filling & Operations Ø Perform aseptic filling of injectable pharmaceuticals in cleanroom environments (ISO 5, ISO 7). Ø Operate and monitor sterile filling equipment (e.g., filling machines, cappers, and autoclaves). Ø Conduct manual and automated sterile filling processes according to batch records and SOPs. Ø Support environmental monitoring by maintaining strict aseptic technique. Ø Participate in line clearance, equipment set-up, in-process checks, and end-of-run reconciliation. Compliance & Documentation Ø Complete all batch records, logbooks, and electronic documentation in real time and with accuracy. Ø Adhere to FDA 503B regulations, cGMP, and internal quality policies. Ø Report deviations, non-conformances, or potential quality issues to supervision immediately. Ø Support regulatory inspections and internal audits as needed. Cleanroom & Equipment Maintenance Ø Follow gowning procedures and aseptic practices required for sterile areas. Ø Assist in cleaning, sanitizing, and maintaining cleanroom areas and equipment. Ø Perform equipment setup, operation, and minor troubleshooting under supervision. Teamwork & Continuous Improvement Ø Work collaboratively with Production Scheduling, Sterile Room, Quality, Microbiology, Engineering, and other Manufacturing teams to ensure smooth sterile production runs. Ø Participate in ongoing training programs to maintain qualifications for cleanroom operations. Ø Suggest process improvements to enhance efficiency, safety, and compliance. Supplemental Functions: Ø Performs all other duties as assigned or apparent. Job Specifications and Qualifications: Education / Experience: Ø High School Diploma or GED required; Associate or Bachelor's in Life Sciences preferred. Ø Minimum 1-2 years' experience in sterile pharmaceutical manufacturing, 503B outsourcing, or hospital compounding strongly preferred. Ø Familiarity with cGMP, FDA 503B guidance, and aseptic technique required. Skills & Competencies: Ø Strong knowledge of sterile gowning and aseptic technique. Ø Ability to work in controlled cleanroom environments. Ø Excellent attention to detail, documentation accuracy, and adherence to SOPs. Ø Strong teamwork and communication skills. Licensing and Certifications: Ø Registered Pharmacy Technician Certification Ø Ability to maintain Gowning Certification _____________________________________________________________________________ Working Conditions / Physical Requirements: Ø Work performed primarily in classified cleanroom environments with strict gowning requirements. Ø Ability to lift up to 40 lbs and stand for extended periods. Ø Requires routine handling of sterile materials, chemicals, and equipment. Ø Shift work, weekends, and overtime may be required based on production demands.

Job Purpose: * Provide real-time QA oversight across BFS and aseptic manufacturing to ensure compliant, accurate, and efficient execution of GMP production activities. * Ensure full adherence to FDA, cGMP, and internal Quality System requirements through on-floor presence, documentation oversight, and cross functional coordination. * Lead, develop, and support the Quality Operations team, promoting a strong culture of compliance, ownership, and right-first-time performance. * Drive operational and quality excellence through proactive issue identification, timely decision-making, and effective cross functional partnerships. * Support continuous improvement initiatives to strengthen documentation practices, reduce deviations, and enhance audit readiness. * Oversee and support Visual Inspection operations Essential Duties and Responsibilities: * Provide daily oversight of BFS and aseptic operations, including observation of critical process steps, cleanroom behaviors, and adherence to established parameters. * Ensure batch execution aligns with cGMPs, SOPs, and documentation standards; review in-process documentation for accuracy, completeness, and right the first time expectations. * Maintain a high state of inspection readiness for regulatory, state, and customer audits through routine walkthroughs, documentation checks, and reinforcement of quality behaviors. * Provide QA oversight of Facilities and Engineering work performed in or impacting GMP areas, including documentation verification and approvals in validated electronic systems. * Support deviation investigations, including documentation of events, fact gathering, root cause analysis, and CAPA implementation. * Ensure timely and accurate review of batch records, logbooks, and supporting documentation; identify trends and error patterns for corrective action. * Collaborate with respective departments to resolve realtime issues and support continuous improvement of processes, documentation, and material flow. * Provide coaching, mentoring, and training for QA and Production personnel regarding documentation accuracy, procedural compliance, and GMP expectations. * Develop, monitor, and report key quality metrics such as right the first time, documentation errors, and operational compliance trends. * Promote contamination control, aseptic discipline, and strong adherence to cleanroom requirements across all shop floor operations. * Communicate quality issues and significant observations promptly to Quality leadership to support timely decision-making and escalation when required. * Ensure visual inspectors are properly trained and qualified for operations. * Verify adherence to approved inspection procedures and support development and maintenance of work instructions and defect libraries. * Perform any other duties related to the Quality Assurance function as necessary or assigned. Job Specifications and Qualifications: Knowledge & Skills: * Strong understanding of cGMPs, FDA regulations, Quality Systems, and documentation requirements supporting sterile manufacturing. * Knowledge of sterility assurance concepts, cleanroom behavior, and contamination control within aseptic or BFS environments. * Experience reviewing batch records, assessing documentation accuracy, and supporting deviation and CAPA processes. * Ability to lead, coach, motivate, and develop Quality Operations personnel. * Strong analytical, problem-solving, and root cause analysis skills. * Effective communication, technical writing, and cross-functional collaboration capabilities. * Proficiency with Microsoft Word, Excel, PowerPoint, and electronic Quality Systems. * Strong attention to detail, time management, and organizational skills. Education/Experience: * Bachelor of Science degree preferred. * 5+ years of Quality Assurance experience in sterile pharmaceutical manufacturing preferred. * 3+ years of supervisory or management experience in a GMP environment preferred. * Experience supporting regulatory inspections and interacting with auditors. * Familiarity with BFS or aseptic production environments strongly preferred. Working Conditions / Physical Requirements: * Requires routine walking through production areas, standing, bending, typing, and lifting up to 40 lbs. * Requires gowning and work within cleanroom environments.

Corporate Statement: Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. ____ Job Purpose: Ø Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations. Ø Ensures the accuracy and completeness of batch records. Ø Performs other duties as assigned or apparent. ____ Essential Duties and Responsibilities: Ø Review Batch Records and applicable documentation to ensure complete, thorough and accurate data. Ø Responsible for ensuring a high level of employee accountability and performance. Ø Maintains quality assurance documentation including shift pass downs. Ø Keep QA work station clean and orderly. Ø Perform packaging line clearances. Ø Pull Retain, Stability, and Lab samples. Ø Perform or verify Quality Finished Product Attribute Inspections. Ø Perform AQL Calculations. Ø Verify component Exhibits Ø Verify all documents are present within the batch record. Ø Support validation and manufacturing studies, including special sampling and testing. Ø Communicate with Management any quality issues identified with product Supplemental Functions: Ø Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations. Ø Assist with development of solutions for chronic problems within quality assurance Ø Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management. Ø Adherence to cGMPs is required at all times. All personnel own the quality of the product delivered and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Ø Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. Ø Assist in other activities (as needed) for Quality Assurance management. ____ Job Specifications and Qualifications: Skills: * Detail oriented. * Technical writing skills required. * Good written, oral and comprehensive communication skills. * Operating computer and relevant software;. * Must be proficient in MS Word, Excel, and PowerPoint; Abilities: * The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication; and provides participation, learning, feedback and recognition. * The ability to effectively manage one's self, demonstrates integrity, be productive under pressure, and achieve development goals. * Ability to handle contending priorities and managing partner expectations * The ability and willingness to change direction and focus to meet shifting organizational and business demands. * Assist in other activities (as needed) for Quality Operations management. * Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law. * Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Education/Experience: * Minimum of High School Diploma or GED required. ____ Working Conditions / Physical Requirements: * This position requires bending, typing, lifting (up to 25 1bs.), standing, sitting and walking throughout the facility. _____ The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace.

Job Purpose: Provide strategic and operational leadership for Quality Operations supporting aseptic manufacturing, including Blow-Fill-Seal (BFS) and conventional sterile filling processes. Ensure full compliance with FDA 503B regulations, cGMP requirements, and applicable regulatory standards by establishing, maintaining, and continuously improving robust Quality Systems. Oversee quality oversight of facilities, utilities, equipment, and environmental monitoring programs to ensure sterility assurance and a sustained state of control. Lead and develop a high-performing Quality Operations organization, fostering a strong culture of quality, data integrity, inspection readiness, and continuous improvement. Partner cross-functionally with Manufacturing, Engineering, and Supply Chain to enable compliant, efficient operations, ensure uninterrupted supply, and serve as the primary Quality representative during regulatory inspections and audits. Essential Duties and Responsibilities: * Provide Quality Operations leadership for aseptic manufacturing, including Blow-Fill-Seal (BFS), conventional sterile filling, visual inspection, and secondary packaging operations. * Ensure compliance with FDA 503B regulations, cGMP requirements, and data integrity standards across all manufacturing and quality activities. * Own and maintain site Quality Systems, including deviations, investigations, CAPA, change control, complaints, and document control. * Provide Quality oversight and approval for batch record review, product disposition, validation activities, and aseptic process controls. * Support sterility assurance programs, including environmental and utilities monitoring, contamination control strategy, and aseptic process simulations. * Lead inspection readiness and serve as the primary Quality representative during FDA, customer, and regulatory audits. * Partner with Manufacturing, Engineering, and Technical Services to support equipment qualification, process changes, capital projects, and technology transfers impacting filling, inspection, and packaging operations. * Lead, develop, and mentor the Quality Operations team while driving a strong culture of quality, compliance, and continuous improvement. * Oversee Quality review and approval of facilities, utilities, and equipment qualification, calibration, maintenance, and lifecycle management activities. * Establish and monitor Quality metrics and KPIs to assess performance, identify trends, and drive continuous improvement initiatives. * Lead, coach, and develop the Quality Operations team, ensuring appropriate staffing, training, and succession planning. * Ensure effective supplier quality management, including qualification, audits, and oversight of critical vendors and contract service providers. * Review and approve procedures, protocols, reports, and quality agreements to ensure regulatory compliance and operational alignment. * Drive a culture of quality, accountability, and continuous improvement across the site. * Escalate quality risks appropriately and ensure timely, effective mitigation to protect patient safety and product quality. Knowledge & Skills: * Comprehensive understanding of FDA regulatory frameworks covering both 503B Outsourcing Facility requirements and cGMP operations, including 21 CFR Parts 210/211 and applicable guidance documents. * Strong expertise in sterility assurance, aseptic processing, environmental monitoring, and contamination control strategies within sterile manufacturing, visual inspection, and secondary packaging. * Experience leading FDA inspections, regulatory audits, and customer audits, with strong inspection readiness and response capabilities. * Proven ability to apply quality risk management principles and data-driven decision-making to ensure product quality and patient safety. * Strong leadership, coaching, and organizational development skills, with the ability to build and sustain high-performing Quality teams. * Effective cross-functional collaboration skills, partnering with Manufacturing, Engineering, Technical Services, and Supply Chain. * Experience with change control, deviation investigations, and CAPA systems within a GMP-regulated manufacturing environment. * Experience with quality approval for process validation and equipment qualification (IQ/OQ/PQ), media fills, cleaning validation, and lifecycle process management. * Proficiency with quality metrics, KPIs, and continuous improvement methodologies to drive compliance and operational excellence. * Strong leadership capabilities with experience coaching and developing high-performing teams across operations and quality. * Prior experience supporting regulatory inspections (FDA, state board of pharmacy, or third-party audits). * Must be detailed oriented and have excellent organizational skills. * Must have excellent communication and technical writing skills. * Ability to drive continuous improvement initiatives while maintaining regulatory compliance and quality standards. * Strong organizational skills with the ability to manage multiple priorities in a fast-paced, regulated environment. Education/Experience: * Bachelor's degree in Engineering, Life Sciences, Pharmacy, Chemistry, or a related scientific/technical discipline required. * Minimum of 10+ years of progressive experience in Quality Assurance / Quality Operations within a cGMP-regulated pharmaceutical or biotechnology environment. * At least 5+ years of leadership experience managing Quality teams supporting sterile manufacturing operations. * Hands-on experience with aseptic processing, visual inspection, and secondary packaging. * Proven experience overseeing Quality Systems such as deviations, investigations, CAPA, change control, and document control. * Experience supporting equipment qualification, process validation, environmental monitoring, and sterility assurance programs. * Strong background in inspection readiness, audit management, and regulatory interactions. * Hands-on experience supporting FDA inspections, regulatory audits, and responses to inspection observations (e.g., FDA Form 483). * Strong background in operational excellence, continuous improvement, and performance management. * Demonstrated ability to lead cross-functional teams while maintaining Quality unit independence and regulatory compliance. * Salary Range: Based on experience Working Conditions / Physical Requirements: * Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing.

Job Purpose: Utilities Maintenance Technicians are to ensure the reliable, efficient, and compliant operations of critical utility systems that support manufacturing. Maintain GMP and non-GMP equipment by preforming preventive maintenance, and repairs on equipment such as: HVAC and cleanroom environmental controls. Purified Water (PW), Water for Injection (WFI), and Pure Steam systems. Boilers, chillers, air compressors, and refrigeration units. Process gases (nitrogen, compressed air) and waste systems. Essential Duties and Responsibilities: Responsible for higher level troubleshooting, repairing, maintaining and directing the installation of all plant utility equipment. Assists with additional work duties or responsibilities as evident or required. Performs other duties as assigned or apparent. Maintain all plant utilities equipment including HVAC, boilers, steam generators, multi-effect still, air compressors, dryers, nitrogen generators, chillers, water pre-treatment, clean room balancing, and other equipment as evident or required. Perform scheduled Upper-Level maintenance. Troubleshoot and perform on demand maintenance. Review and evaluate equipment data. Ensuring procedures are followed when performing maintenance. Back-up and assist all other Utility Maintenance personnel. Daily plant walkthroughs to ensure problems are caught before production demands are jeopardized. Ability to follow cGMP's and good documentation practices. Supplemental Functions: · Copying, filing, and scanning of documents. Performs other similar duties as required. Job Specifications and Qualifications: Knowledge & Skills: The ability to take strategic objectives and accept accountability to drive results through effective actions. The ability and willingness to change direction and focus to meet shifting organizational and business demands. The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. The ability to create new products and processes that add value to the Business by generating new ideas and applying creative and analytical approaches. Must speak, write, and read English. Specific expertise, skills and knowledge within maintenance gained through education and experience. Rotating shift work may be required. Shift assignment may be adjusted as needed. Salary range: Based on experience Must pass a Drug Test. Education/Experience: · Engineering degree or 8-10+ years equivalent experience · Prior electrical/electronic/controls and/or mechanical/vibration analysis experience · Knowledge of the Pharmaceutical Industry preferred Working Conditions / Physical Requirements: Position requires lifting (up to 50lbs), bending, climbing, reaching, good vision, standing, sitting, walking, gripping, talking, and hearing. Incumbents required to wear safety glasses, hearing protection and other non-specified protective equipment as necessary. Incumbents are exposed to the following environmental factors: heat, cold, and water. Salary Description Hourly: $30.00/hr - $40.00/hr based on experience

Job Purpose: The Sterile Filling Technician is responsible for performing aseptic filling and related sterile operations within a 503B outsourcing pharmaceutical manufacturing facility. This role ensures products are prepared, filled, and packaged in compliance with FDA 503B regulations, cGMP standards, and company SOPs to ensure product quality and patient safety. __________________________________________________________________________________________ Essential Duties and Responsibilities: Sterile Filling & Operations Ø Perform aseptic filling of injectable pharmaceuticals in cleanroom environments (ISO 5, ISO 7). Ø Operate and monitor sterile filling equipment (e.g., filling machines, cappers, and autoclaves). Ø Conduct manual and automated sterile filling processes according to batch records and SOPs. Ø Support environmental monitoring by maintaining strict aseptic technique. Ø Participate in line clearance, equipment set-up, in-process checks, and end-of-run reconciliation. Compliance & Documentation Ø Complete all batch records, logbooks, and electronic documentation in real time and with accuracy. Ø Adhere to FDA 503B regulations, cGMP, and internal quality policies. Ø Report deviations, non-conformances, or potential quality issues to supervision immediately. Ø Support regulatory inspections and internal audits as needed. Cleanroom & Equipment Maintenance Ø Follow gowning procedures and aseptic practices required for sterile areas. Ø Assist in cleaning, sanitizing, and maintaining cleanroom areas and equipment. Ø Perform equipment setup, operation, and minor troubleshooting under supervision. Teamwork & Continuous Improvement Ø Work collaboratively with Production Scheduling, Sterile Room, Quality, Microbiology, Engineering, and other Manufacturing teams to ensure smooth sterile production runs. Ø Participate in ongoing training programs to maintain qualifications for cleanroom operations. Ø Suggest process improvements to enhance efficiency, safety, and compliance. Supplemental Functions: Ø Performs all other duties as assigned or apparent. Job Specifications and Qualifications: Education / Experience: Ø High School Diploma or GED required; Associate or Bachelor's in Life Sciences preferred. Ø Minimum 1-2 years' experience in sterile pharmaceutical manufacturing, 503B outsourcing, or hospital compounding strongly preferred. Ø Familiarity with cGMP, FDA 503B guidance, and aseptic technique required. Skills & Competencies: Ø Strong knowledge of sterile gowning and aseptic technique. Ø Ability to work in controlled cleanroom environments. Ø Excellent attention to detail, documentation accuracy, and adherence to SOPs. Ø Strong teamwork and communication skills. Licensing and Certifications: Ø Registered Pharmacy Technician Certification Ø Ability to maintain Gowning Certification _____________________________________________________________________________ Working Conditions / Physical Requirements: Ø Work performed primarily in classified cleanroom environments with strict gowning requirements. Ø Ability to lift up to 40 lbs and stand for extended periods. Ø Requires routine handling of sterile materials, chemicals, and equipment. Ø Shift work, weekends, and overtime may be required based on production demands.