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The Ritedose jobs in Columbia, SC

- 24 jobs
  • Packaging Associate

    The Ritedose Corporation 4.0company rating

    The Ritedose Corporation job in Columbia, SC

    Job Details The Ritedose Corporation - Columbia, SC 8A High School $16.55 - $16.55 Hourly ManufacturingDescription The Packaging Associate is responsible for the inspection and packaging of ampoules and the support of the packaging line. Responsibilities: Inspect and package ampoules for both Packaging and Bulk. Transport packaging materials from airlock to the appropriate packaging line in the packaging area. Take wet scrap to rejected material cage. Take rejected raw materials to the rejected material cage. Keep a clean and orderly workplace. Participate in the internal and external TRC training program. Maintain a professional team-oriented working relationship with fellow employees. Follow TRC SOPs, safety and health guidelines and c-GMP Guidelines. Follow written and verbal procedures as directed by management and Ritedose. Qualifications Qualifications: High School Diploma or GED Ability to spend a majority of time standing Ability to participate and develop a team-oriented working relationship within the production area.
    $16.6-16.6 hourly 60d+ ago
  • Audit Manager

    The Ritedose Corporation 4.0company rating

    The Ritedose Corporation job in Columbia, SC

    Job Details The Ritedose Corporation - Columbia, SC $85000.00 - $95000.00 Salary/year Description The Audit Manager is responsible for the internal audit program, supplier quality management and coordination/execution of customer and regulatory audits. Responsibilities: Ensure execution of internal audits according to the Internal Audit Master Plan Track the execution of corrective action implementation of audit findings Provide oversight to supplier quality management process Conduct supplier audits including on-site inspections when required Maintain a history of audits performed and schedule repeat audits as required Coordinate and manage supplier quality alerts Coordinate and participate in regulatory and customer audits Perform trending of audit findings and identify opportunities for improvement Maintain current knowledge of regulations and guidance documents Manage and mentor audit personnel Qualifications: Four year college degree in Pharmacy, Chemistry, Biology or related field 5-10 years' experience in the pharmaceutical industry with a quality background Thorough knowledge of cGMP/ 21CFR with related experience in regulatory and compliance ASQ Certified Quality Auditor required Experience with FDA audits Proficient with current word processing and database software Strong interpersonal/group skills with ability to motivate and direct others Strong communication skills, verbal and written Qualifications Qualifications: Four year college degree in Pharmacy, Chemistry, Biology or related field 5-10 years' experience in the pharmaceutical industry with a quality background Thorough knowledge of cGMP/ 21CFR with related experience in regulatory and compliance ASQ Certified Quality Auditor required Experience with FDA audits Proficient with current word processing and database software Strong interpersonal/group skills with ability to motivate and direct others Strong communication skills, verbal and written
    $85k-95k yearly 60d+ ago
  • BFS Line Technician I

    Nephron Pharmaceuticals 4.3company rating

    West Columbia, SC job

    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.
    $28k-39k yearly est. 15d ago
  • Payroll Manager

    Nephron Pharmaceuticals Corp 4.3company rating

    West Columbia, SC job

    Job Purpose: To oversee the entire payroll process to ensure employees are paid accurately and on time, while also guaranteeing compliance with all relevant laws and tax regulations. Key duties include managing payroll staff, supervising payroll systems, ensuring accurate tax withholdings and deductions, and collaborating with HR and finance/ accounting departments. Essential Duties and Responsibilities: Ø Accurately manage, prepare, complete and maintain payroll using Paylocity payroll system for both exempt and non-exempt employees. Ø Review employee tax setup to ensure compliance with Federal and State regulatory requirements and Nephron's policies and procedures. Ø Respond to employee inquiries regarding payroll matters, e.g. time off requests, payroll and tax forms, etc. Ø Assist with quarterly payroll tax, year-end payroll and W-2 reconciliations. Ø Work with the accounting department to update general ledger as it pertains to payroll and health claims. Ø Prepares reports from Paylocity as needed by approved members of Management. Ø Conducts audits to ensure integrity of employee time. Ø Reports abuse of time to HR leadership. Ø Manages Payroll and HR Assistant. Primary Accountabilities: Ø Assist with Department of Labor /Wage garnishment requirements. Ø Assist with employee payroll questions and concerns. Ø Runs various payroll reports as needed by approved members of company leadership. Ø Assists with leave and attendance administration. Ø Handles confidential information relating to payroll. Ø All other projects or tasks requested by HR leadership. Supplemental Functions: Ø Perform other duties as assigned or apparent. Job Specifications and Qualifications: Knowledge: Ø Proficient in Paylocity Payroll system. Ø Microsoft Office experience. Advanced Excel abilities required. Ø Experience with Department of Labor and SC Employment Law preferred. Ø Experience with benefits, specifically insurance related issues preferred. Ø Clear communication skills. Ø Must be detail oriented, open-minded, have interpersonal skills, and be able to resolve conflict in a productive manner. Ø Specific expertise, skills and knowledge within the functional area of human resources gained through education and experience. Ø The ability and willingness to change direction and focus to meet shifting organizational and business demands. Ø The ability to create and contribute in an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. Ø The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals. Education/Experience: Ø Associates degree in finance/ payroll or a related field, with five (5+) years of experience of progressive finance/ payroll experience or equivalent combination of education with years of experience to perform the essential duties of the position. (Bachelor's degree preferred) Licensing and Certification: Ø American Payroll Association Fundamental Payroll Certification (FPC) or Certified Payroll Professional (FPC) preferred. Working Conditions / Physical Requirements: Ø This position requires bending, typing, lifting (up to 20 1bs.), standing, sitting and walking throughout the facility.
    $49k-66k yearly est. 2d ago
  • Director of Production Operations

    Nephron Pharmaceuticals 4.3company rating

    West Columbia, SC job

    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, suspensions, injectables, and ophthalmics. Nephron is currently working on research and development projects that include over 50 new products. 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: • Oversee end-to-end BFS (Blow-Fill-Seal) and aseptic production processes to ensure efficient, safe, and compliant product manufacturing. • Ensure full adherence to FDA 503B requirements and cGMP standards across all production activities. • Lead and develop a high-performing production team while promoting a strong culture of quality, safety, and sterility assurance. • Drive operational performance through effective resource planning, productivity management, and process optimization. • Support continuous improvement initiatives to enhance throughput, reduce waste, and maintain audit readiness. • Ensure production outputs meet quality standards, customer requirements, and business objectives. Essential Duties and Responsibilities: • Direct daily operations for BFS filling and aseptic compounding. • Ensure production schedules, batch execution, and resource planning meet output, quality, safety, and service requirements. • Maintain high operational performance through effective coordination with Quality, Supply Chain, Engineering, and Technical Services. • Ensure all production activities adhere to FDA 503B Outsourcing Facility regulations, cGMP requirements, and internal SOPs. • Maintain ongoing inspection readiness for FDA, state boards of pharmacy, and customer audits. • Oversee the performance and efficiency of BFS equipment, tooling, and operating parameters. • Support troubleshooting, preventive maintenance, and equipment optimization in partnership with applicable departments. • Ensure timely and accurate documentation, including batch records, logbooks, and equipment records. • Support investigation of deviations and equipment failures; ensure effective CAPA implementation. • Uphold strict data integrity standards across all production activities. • Drive process optimization, waste reduction, and material flow improvements across BFS and aseptic areas. • Plans, monitors, and analyzes key metrics for day-to-day operations to ensure efficient and timely completion of tasks. • Provides leadership and mentors production personnel, fostering a high-performing, cross-functional team and culture of continuous improvement, accountability, and operational excellence. • Promotes a strong quality mindset through leadership visibility, mentoring, and ownership of performance metrics. • Partners with executive leadership on growth strategy, capacity planning, and improvement efforts across the division. • Ensure compliance with applicable EH&S standards and facility safety policies. • Promote strong aseptic discipline, contamination control practices, and cleanroom behavior. • Performs any other duties as necessary or assigned. 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. • Proficiency in compounding and sterile formulation processes, filtration, solution preparation, and material flow in classified environments. • Experience with process validation and equipment qualification (IQ/OQ/PQ), media fills, cleaning validation, and lifecycle process management. • Demonstrated success implementing Lean, Six Sigma, and operational excellence initiatives to improve efficiency, yields, and throughput. • Strong leadership capabilities with experience coaching and developing high-performing teams across operations, quality, and engineering functions. • 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. Education/Experience: • Bachelor's degree in Engineering, Life Sciences, Pharmacy, Chemistry, or a related scientific/technical discipline required. • Advanced degree (MBA, MS, MEng, PharmD, or equivalent) preferred. • 10+ years of sterile pharmaceutical manufacturing experience in cGMP environments, with progressive leadership responsibilities. • Direct experience in GMP manufacturing, including familiarity with regulatory expectations, validation requirements, and quality system standards. • 5+ years of supervisory or management experience leading production teams in aseptic or BFS operations. • In-depth knowledge of pharmaceutical compounding processes, regulations, and industry best practices. • Experience with cGMP documentation systems and with implementation of quality control systems. • Preferred experience in Six-Sigma and Lean Manufacturing methodologies. • Salary Range: Based on experience Working Conditions / Physical Requirements: • Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing. 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.
    $100k-135k yearly est. 17d ago
  • Sterile Room Technician Tier I - Nights 6:00 PM - 6:30 AM

    Nephron Pharmaceuticals 4.3company rating

    West Columbia, SC job

    Salary Description $23.00/Hr
    $23 hourly 42d ago
  • AS Chemist III

    The Ritedose Corporation 4.0company rating

    The Ritedose Corporation job in Columbia, SC

    Job Details The Ritedose Corporation - Columbia, SC 2C 4 Year Degree $31.83 - $35.01 Hourly ScienceDescription The Analytical Services Chemist III role is for a laboratory professional with responsible for performing analytical testing related to raw materials, compounding support activities, and final product testing in the Analytical Services Laboratory. In addition, the Analytical Services Chemist III role will support analytical method validations and transfers, as well as product development studies. Responsibilities: Performing chemical raw material (sampling, testing and release), in-process (including product formulation activities), and final product including stability and complaint sample testing. Notify Laboratory Management immediately of out of specification results and assist in the investigations of OOS and deviations as assigned by Laboratory Management. Responsible for performing tests associated with method validations and transfers as assigned, including cleaning and equipment validations. Responsible for laboratory notebook data, batch record data, and report review when assigned. Assist in special projects and regulatory audits as requested by the Laboratory Management. Assist in collaboration of laboratory SOPs when requested. Responsible for assisting with the training of junior personnel when requested. Responsible for ensuring that routine maintenance and troubleshooting of instrumentation, is performed as stated in the instrument manual and contacting the manufacturer for assistance when needed. Responsible for the general maintenance of the Chemistry Laboratory including good housekeeping and a safe working environment. Follow Standard Operating Procedures, documentation, safety, health, and cGMP Guidelines. Qualifications BS degree in Chemistry or related field with a minimum 4 years of experience, or a MS degree in Chemistry or related field with a minimum 2 years of experience, in a pharmaceutical laboratory environment required. Expertise with standard laboratory techniques, wet chemistry tests, titration, spectroscopy, HPLC, GC, and modern Data Acquisition Systems required. Competency with specialized laboratory equipment such as ICP-MS, Malvern PSD, aPSD, Particulate Matter testing, Breathing Simulation Testing, etc. is desirable Strong documentation skills and proficiency with current word processing, spreadsheets, and database software required Must be detail focused, have a strong work ethic, and the ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within the laboratory and between other departments
    $31.8-35 hourly 55d ago
  • Utility Maintenance Manager - GMP Pharmaceutical Manufacturing

    Nephron Pharmaceuticals 4.3company rating

    West Columbia, SC job

    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.
    $53k-77k yearly est. 23d ago
  • Bulk Operations Supervisor

    The Ritedose Corporation 4.0company rating

    The Ritedose Corporation job in Columbia, SC

    Job Details The Ritedose Corporation - Columbia, SC 1D Swing ManufacturingDescription The Bulk Operations Supervisor will manage the Bulk Operations process at the shift level. They will work a continuous work week schedule as required by production demands, and will have the supervisory responsibility for the Bulk Operations personnel on the shift. They will be responsible for ensuring that the process complies with all cGMP and validation requirements at all times, which includes the control of all environmental factors. They will work closely with Process Control resources to ensure that all product quality targets are met and that all process issues are appropriately reported, investigated, and corrected. Responsibilities: Ensure that all products consistently meet TRC quality standards and that the process operates in a state of control Ensuring the production schedule for the shift is appropriately communicated and understood Reporting execution variances to the production schedule Identifying areas for improvement in the execution of the schedule Assisting with the development of communication tools to improve the overall process Communicating any emergency changes to the schedule that come from the plant leadership team Ensuring that the Resin Room and Resin Silos are operating as required Ensuring that downtime information is entered into the downtime database as required Ensuring the departmental review of Batch Records is performed as required Involvement in continuous improvement projects Revise or develop SOP's as required Support all TRC and departmental goals Maintain material inventories in the ERP system as required Ensure that team members' training is completed as required Ensure that the plant utilities equipment is operating as needed Manage safety incidents per appropriate SOP's Communicate departmental goals/expectations as well as individual goals to all team members Provide coaching/counseling to team members as necessary Conduct employee performance evaluations annually at a minimum Support the proactive maintenance effort by ensuring that maintenance work requests are written into the computerized maintenance management system Communicate openly with all areas of the plant Ensure that the change control process is followed as required Support validation activities as needed Notify appropriate personnel when relevant situations arise that require additional support Qualifications: Technical degree or equivalent work experience Experience in a cGMP environment Minimum of 5 years experience in manufacturing Ability to handle and establish multiple priorities and meet expectations with minimal supervision Ability to work within a team oriented operation Able to use Microsoft Office and other Windows based software Strong oral and written communication skills
    $37k-57k yearly est. 48d ago
  • Bulk Operations Tech- Basic Skills

    The Ritedose Corporation 4.0company rating

    The Ritedose Corporation job in Columbia, SC

    Job Details The Ritedose Corporation - Columbia, SC 6B High School $25.43 - $25.43 Hourly Swing ManufacturingDescription The Bulk Operations Technician- Basic Skills is responsible for starting, operating, cleaning, and assisting the BFS Technician in performing maintenance on production equipment. Responsible for timely documentation of work performed. Responsibilities: Obtain and keep a good working knowledge, assist in performing routine, preventative, and unscheduled maintenance on the following production equipment: Blow-Fill-Seal Machines Resin Handling Equipment Preparing the BFS machines for batch filling. Tasks typically include: changing code magazines, ensuring proper filters are in place and properly tested, connecting the appropriate holding tank to the fill suite, steam sterilization, filter drying, starting the BFS and making initial mechanical and filling adjustments. Monitor the BFS machines and support equipment during the batch filling. Perform routine shift checks and document appropriately. Make adjustments to ampoule weight, forming, and fill volume during batch filling as needed to maintain process control. Performing shutdown procedures at the completion of the batch filling. Tasks typically include: disconnecting the holding tank from the fill suite, in-line WFI cleaning, internal surface cleaning, product filter integrity testing, steaming molds, and changing filters if necessary. Perform filter integrity test on air filters and document appropriately. Perform routine preventative maintenance on the BFS equipment Maintain housekeeping of area and equipment. Maintain complete and accurate documentation of activities to support product disposition. Participate in the internal and external training program. Maintain a professional team-oriented working relationship with fellow employees. Follow Ritedose SOPs, safety and health guidelines and c-GMP Guidelines. Perform routine maintenance on BFS machines. Physical Requirements: Ability to frequently lift and carry up to 40 pounds of equipment, parts or supplies. Qualifications 2 year technical degree or equivalent experience in a manufacturing environment Mechanical or electrical experience in a manufacturing environment. Ability to establish priorities and operating equipment quality expectations. Ability to participate and develop a team-oriented working relationship within the operation.
    $25.4-25.4 hourly 48d ago
  • Manager of Financial Planning and Analysis (FP&A)

    Nephron Pharmaceuticals 4.3company rating

    West Columbia, SC job

    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.
    $84k-108k yearly est. 60d+ ago
  • Facilities Technician

    The Ritedose Corporation 4.0company rating

    The Ritedose Corporation job in Columbia, SC

    Job Details The Ritedose Corporation - Columbia, SC 9A $18.16 Hourly Day Installation - Maint - RepairDescription The Facilities Technician is responsible for the daily upkeep and maintenance of the facility buildings, as well as performing various functions that support the facility as needed. Responsibilities: Daily cleaning maintenance of the interior and exterior of the facility Maintaining cleanliness of the facility grounds External building and window pressure washing and cleaning as required Trash removal from cafeteria and outside receptacles Disposal of trash from collection points to final waste collection sites Cleaning warehouse racks, equipment, ledges, and other items as required Working with outside cleaning companies to ensure quality of work performed Oversee cleaning activities around construction projects Various minor construction tasks, such as dry wall and paint repairs, as required Assist Facility Manager in other related facilities tasks as needed Assist Hygiene staff with cleaning duties as required Follow Standard Operating Procedures, safety and cGMP guidelines Qualifications: High School Diploma or GED Ability to prioritize and implement tasks with minimal supervision Good interpersonal and group skills Must possess good oral communication skills
    $18.2 hourly 48d ago
  • Quality Operations Primary Packaging Tier I (Shift 4 6:00 PM - 6:30 AM)

    Nephron Pharmaceuticals 4.3company rating

    West Columbia, SC job

    Requirements Knowledge, Skills & Abilities: High School Diploma or GED. Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of cGMP preferred. 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 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. 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. Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25 lbs.), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing, and hearing. Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary.
    $26k-33k yearly est. 37d ago
  • Sterile Room Technician Tier I - Nights 6:00 PM - 6:30 AM

    Nephron Pharmaceuticals Corp 4.3company rating

    West Columbia, SC job

    Job Purpose: Oversees the sanitizing of the "cleanrooms", clean unclassified areas and changing rooms to ensure the pharmaceutical products meet quality and productivity requirements along with cGMP and OSHA regulations. Assists with additional work duties or responsibilities as evident or required. Essential Duties and Responsibilities: * Sanitizing of classified areas per approved procedures * Cleaning of clean unclassified dedicated areas * Re-stock clean room supplies daily * Prepare sanitation solutions daily * Performs other duties as assigned or apparent. Supplemental Functions: * Ability to climb ladders. * Performs other similar duties as required. Job Specifications and Qualifications: Knowledge & Skills: * Detail oriented and ability to work independently or as a team. * Previous sanitizing experience of sterile environment preferred * Incumbent must be able to work 12-hour days without fatigue. * Position requires performing tasks that involve strenuous repetitive activities. Incumbents must have excellent stamina. * Incumbents are required to perform full range of motion in fingers, wrists, elbows and shoulders. * The ability and willingness to change direction and focus to meet shifting organizational and business demands. * 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 self, demonstrates integrity, be productive under pressure, and achieve development goals. * The ability to take strategic objectives and accept accountability, motivate and influence others. * The ability to manage a multitude of resources and to be accurate, organized and current with data and information. * Incumbents are required to wear safety glasses/face shields, hearing protection, bouffant, respirator, tyvex coveralls and other non-specified protective equipment as necessary for extended periods of time. * Salary range: Based on experience Education/Experience: * Minimum High School Diploma or equivalent. * Previous manufacturing / production work experience preferred * Gowning Certification preferred. Working Conditions / Physical Requirements: * Position requires, bending, lifting (up to 20 lbs.), reaching overhead for extended periods of time, visual acuity, and standing, sitting and walking.
    $31k-37k yearly est. 42d ago
  • Director of Production Operations

    Nephron Pharmaceuticals Corp 4.3company rating

    West Columbia, SC job

    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, suspensions, injectables, and ophthalmics. Nephron is currently working on research and development projects that include over 50 new products. 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: * Oversee end-to-end BFS (Blow-Fill-Seal) and aseptic production processes to ensure efficient, safe, and compliant product manufacturing. * Ensure full adherence to FDA 503B requirements and cGMP standards across all production activities. * Lead and develop a high-performing production team while promoting a strong culture of quality, safety, and sterility assurance. * Drive operational performance through effective resource planning, productivity management, and process optimization. * Support continuous improvement initiatives to enhance throughput, reduce waste, and maintain audit readiness. * Ensure production outputs meet quality standards, customer requirements, and business objectives. Essential Duties and Responsibilities: * Direct daily operations for BFS filling and aseptic compounding. * Ensure production schedules, batch execution, and resource planning meet output, quality, safety, and service requirements. * Maintain high operational performance through effective coordination with Quality, Supply Chain, Engineering, and Technical Services. * Ensure all production activities adhere to FDA 503B Outsourcing Facility regulations, cGMP requirements, and internal SOPs. * Maintain ongoing inspection readiness for FDA, state boards of pharmacy, and customer audits. * Oversee the performance and efficiency of BFS equipment, tooling, and operating parameters. * Support troubleshooting, preventive maintenance, and equipment optimization in partnership with applicable departments. * Ensure timely and accurate documentation, including batch records, logbooks, and equipment records. * Support investigation of deviations and equipment failures; ensure effective CAPA implementation. * Uphold strict data integrity standards across all production activities. * Drive process optimization, waste reduction, and material flow improvements across BFS and aseptic areas. * Plans, monitors, and analyzes key metrics for day-to-day operations to ensure efficient and timely completion of tasks. * Provides leadership and mentors production personnel, fostering a high-performing, cross-functional team and culture of continuous improvement, accountability, and operational excellence. * Promotes a strong quality mindset through leadership visibility, mentoring, and ownership of performance metrics. * Partners with executive leadership on growth strategy, capacity planning, and improvement efforts across the division. * Ensure compliance with applicable EH&S standards and facility safety policies. * Promote strong aseptic discipline, contamination control practices, and cleanroom behavior. * Performs any other duties as necessary or assigned. 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. * Proficiency in compounding and sterile formulation processes, filtration, solution preparation, and material flow in classified environments. * Experience with process validation and equipment qualification (IQ/OQ/PQ), media fills, cleaning validation, and lifecycle process management. * Demonstrated success implementing Lean, Six Sigma, and operational excellence initiatives to improve efficiency, yields, and throughput. * Strong leadership capabilities with experience coaching and developing high-performing teams across operations, quality, and engineering functions. * 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. Education/Experience: * Bachelor's degree in Engineering, Life Sciences, Pharmacy, Chemistry, or a related scientific/technical discipline required. * Advanced degree (MBA, MS, MEng, PharmD, or equivalent) preferred. * 10+ years of sterile pharmaceutical manufacturing experience in cGMP environments, with progressive leadership responsibilities. * Direct experience in GMP manufacturing, including familiarity with regulatory expectations, validation requirements, and quality system standards. * 5+ years of supervisory or management experience leading production teams in aseptic or BFS operations. * In-depth knowledge of pharmaceutical compounding processes, regulations, and industry best practices. * Experience with cGMP documentation systems and with implementation of quality control systems. * Preferred experience in Six-Sigma and Lean Manufacturing methodologies. * Salary Range: Based on experience Working Conditions / Physical Requirements: * Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing. 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.
    $100k-135k yearly est. 16d ago
  • BFS Line Technician I

    Nephron Pharmaceuticals Corp 4.3company rating

    West Columbia, SC job

    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.
    $28k-39k yearly est. 42d ago
  • Manager of Financial Planning and Analysis (FP&A)

    Nephron Pharmaceuticals Corp 4.3company rating

    West Columbia, SC job

    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.
    $84k-108k yearly est. 60d+ ago
  • Utility Maintenance Manager - GMP Pharmaceutical Manufacturing

    Nephron Pharmaceuticals Corp 4.3company rating

    West Columbia, SC job

    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.
    $53k-77k yearly est. 22d ago
  • Quality Operations Primary Packaging Tier I (Shift 4 6:00 PM - 6:30 AM)

    Nephron Pharmaceuticals Corp 4.3company rating

    West Columbia, SC job

    * Performs Weight Check and Quality Attributes Inspection of the product through the filling and packaging process in compliance with company policies/procedures, FDA and cGMP regulations. * Ensures the accuracy and completeness of batch records. * Performs other duties as assigned or apparent. Primary Accountabilities: * Successfully complete required Quality Assurance Training as outlined per procedure. * Successfully complete DEA certification. * Review production batch records for accuracy and completeness. * Monitor and perform start up, in-process and finished product inspections including weight checks and attribute inspections during production. * Maintain quality assurance documentation. * Promote teamwork both within the QA area and other departments. * Keep line and work station clean and orderly. * Inspect and release machines and processing rooms for production. * Support validation and manufacturing studies including special sampling and testing. * Organize workload during lot and batch changeovers for efficient execution. * Review and approve production batch records for release into production. * Investigate out of range percentages. Shop Floor QA Accountabilities: * 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. Requirements Knowledge, Skills & Abilities: * High School Diploma or GED. * Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of cGMP preferred. * 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 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. * 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. * Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25 lbs.), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing, and hearing. * Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary.
    $26k-33k yearly est. 36d ago
  • UTILITIES MAINTENANCE TECHNICIAN

    Nephron Pharmaceuticals 4.3company rating

    West Columbia, SC job

    Salary Description Hourly: $30.00/hr - $40.00/hr based on experience
    $30-40 hourly 14d ago

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