Strides Pharma jobs - 23 jobs

Job Description The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product. Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements. Mentor staff and set goals and objectives for the production personnel. Chestnut Ridge Operations 1st & 2nd shift Key Accountabilities Accountability & Responsibilities Manufacturing Operations Management Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities. Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation. Assure the accurate packaging of drug product in approved primary packaging components without deviation. Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories. Assure the accurate assessment of component inventory and reconciliation. Assure staff training requirements are established and complete prior to the performance of process or procedure. Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators. Establish performance Goals and Objectives based on facility needs and High Corporate Standards. Complete routine performance evaluations of staff and recommend growth opportunities. Assure adherence to established production schedules and monitor production performance as determined by the Plant Director. Monitor the general safety of staff and assure safe work practices are followed by all site personnel. Education & Experience Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience. 10 years' experience in a pharmaceutical manufacturing environment. Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years' previous supervisory experience required. Knowledge Knowledge of workplace health and safety requirements for applicable hazardous substances. Must be able to demonstrate a high degree of understanding in the cGMP practices. Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations. Skills & Abilities Demonstrate knowledge of the current good manufacturing practices. Ability to convey information clearly and concisely to both individuals and groups. Ability to troubleshoot manufacturing processes, write investigations and complete documentation. Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity. Physical Requirements This position requires working with or around hazardous substances and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees. Ability to don personal protective equipment, if necessary. Able to walk the production floor. This position requires working with or around hazardous substances and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees. Ability to don personal protective equipment, if necessary. Able to walk the production floor.

Job Description With advanced and specialized packaging knowledge, oversees and manages the daily operation of a packaging line. Performs functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). This role supervises the day-to-day activities of the Operators and provides guidance on tasks that are being performed on the line. Often, this position is involved in the Operator interview process but are not decision makers in terms of hiring decisions, promotions, annual evaluations, etc. This role is recognized as a process expert, and is qualified as a certified trainer and provides training to less senior Operators. Proactively identifies and performs root cause analysis, in conjunction with other operators/technicians, makes recommendations, and aids in implementation. Responsible for the safe and efficient execution of job duties, while ensuring product compliance to established standards. Oversees and coordinates packaging lines for single location. May fill in for supervisor as necessary. Responsibilities Packaging Operations Coordinates each Operator's responsibilities during each shift. Monitors the packaging process to ensure schedule is met within standards. Conducts final audit of Batch Records, including SAP transactions, prior to going to Packaging BR Reconciler; Is qualified and capable of running all packaging equipment across the entire packaging department. Conducts preliminary review of all daily Batch Production Record (BPR) for the line and logbook documentation to ensure detail and accuracy. Accurately reviews BPR's steps for completeness and accuracy. Request components, labels and inserts per the BPR. Set up packaging machinery; accurately sets equipment programming according to BPR's and SOP's. Conduct basic set ups, starts, operates, adjusts, troubleshoots and tears down packaging lines. Conduct sampling: Collects samples from each batch and submits to QA for retained samples. Executes procedures to complete tasks in a compliant and safe manner. Equipment Cleaning Conducts verification of line/equipment cleaning and documents per SOP. Executes procedures used to clean pharmaceutical packaging equipment and facilities. Competently conducts Master Cleans and Line Clearances. Continuous Improvement Captures and reports metrics; troubleshoots downtime in order to increase operational efficiency. Lead or participate in Continuous Improvement projects. Troubleshoots and resolves process issues. Issues & Deviations Performs defect evaluations and initiates production event logs. Identifies, reports, and suggests resolutions for processing related issues. Assists in the investigation of unplanned deviations. Quality Executes the required in-process product quality checks and documents accurately. Teamwork and collaboration Communicates and coordinates change-overs and other equipment downtime issues to Reliability Technicians. Interfaces with supervisor and/or Quality personnel to inform of deviations or other line issues. Continuous Training Is qualified as a certified trainer and provides training to less senior operators. Stays current on SOPs and cGMPs. Continuous Safety & Compliance Contribute to safety audits. Carries out processing/packaging activities safely, as required, on a daily basis. Follows all safety and compliance procedures and participates in required training. Adheres to all cGMP compliance/regulatory mandates and quality requirements. Participate in safety teams, start-up discussions, incident debriefs, etc. Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies. Misc Other related duties as assigned to meet departmental and Company objectives. Qualifications High school diploma or equivalent. Minimum of 3 years of related packaging experience and/or proficiency demonstrated in competencies as required. Knowledge Thorough knowledge of cGMP regulations and processes. Thorough knowledge of manufacturing and packaging operations. Skills & Abilities Ability to oversee and manage the daily operation of a packaging line. Qualified and capable of running all packaging equipment across the entire packaging department. Ability to monitors processes to ensure schedule is met within standards. Ability to conduct final audits of Batch Records, including SAP transactions, prior to going to Packaging BR Reconciler. Certified Trainer of others. Ability to analyze metrics and troubleshoot downtime in conjunction with other specialists. Effectively interfaces with Quality and supervisor to inform of deviations or other line issues. Demonstrates the ability to work in collaboration with others as a part of a team. Ability to lead or participate in Continuous Improvement projects. Good communication skills. Good attention to detail in order to conduct final audits and reviews. Ability to follow both verbal and written instructions including SOP's and Batch Record documentation. Ability to accurately and precisely record data and batch information. Ability to work in both independent and team environments. Proficient in reading and writing English to understand work instructions and document results. Physical Requirements Must be able to stand for long periods of time (8 or 12 hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes. Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects. Vision - ability to see details at close range (within a few feet of the observer). Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.

Job Description Associate, Quality Assurance (Sampling) Department: Quality Assurance The Entry-Level Associate, Quality Assurance supports the sampling activities and shop floor quality operations at the Chestnut Ridge site. Roles and Responsibilities Raw Material Sampler Key Responsibilities: Cleaning/Approving: Cleaning, approving and preparing the sampling room and utensils for raw material sampling according to established procedures. Inspection of Materials: Visually inspecting raw materials and packaging components for any damage, defects, or non-conformities before and during sampling. Sampling: Collecting samples of incoming raw materials and packaging components from various vendors, warehouses or storage locations according to established GMP (Good Manufacturing Practice) and quality control procedures. Documentation and Labeling: Accurately labeling and documenting samples with all relevant information (e.g., lot number, including sample details, date, time, and any relevant observations) and maintaining thorough records of all sampling activities. Sample Handling and Delivery: Ensuring samples are stored correctly and securely and maintaining their integrity until they are delivered to the appropriate laboratories for testing (e.g., microbiology, chemistry, packaging). Testing: Submitting samples to the laboratory for testing and analysis, often coordinating with lab personnel. Record Keeping: Maintaining detailed records of all sampling activities, including test results and any deviations or discrepancies. Communication: Effectively communicating with warehouse, procurement, and laboratory teams to coordinate sampling schedules, report discrepancies, and ensure a smooth workflow. Inventory Management: Assisting with inventory tracking and the organization of raw materials in storage areas. Safety Compliance: Following all safety protocols and procedures to prevent contamination and ensure a safe working environment. Maintaining a Clean Work Environment: Ensuring the cleanliness and hygiene of sampling areas and equipment, especially in controlled environments. Calibration and Maintenance: Calibrating or verifying the calibration of sampling instruments and maintaining supplies as needed. Troubleshooting and Problem-Solving: Identifying and reporting any quality variances or issues with incoming materials and assisting in investigations of raw material complaints. Compliance: Adhering strictly to all relevant safety procedures, regulatory requirements (like GMP), and company procedures to prevent contamination and ensure accurate results Education & Experience Required Education: High school or Bachelor's degree in Pharmaceutical Sciences or a related field. Experience: 1-3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable). Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred. Physical Requirements On-site role at Pearl River, NY. Standard work hours: 7 AM to 4 PM. No travel required. Able to lift 50 lbs.

The Lab Sample Coordinator, under direct supervision, performs QC laboratory sample receipt, processing, distribution for testing, storage and reconciliation through to disposal. Performs reference standards, chromatographic columns receipt, distribution, monitoring. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Accountability & Responsibilities Sample Management Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage Performs QC sample reconciliation and disposal Tracks inventory of product samples, stability samples, and test materials in the lab Uses laboratory software for sample, reference standard, chromatographic column management Verifies accuracy of labeling/documentation provided with samples Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area. Send samples for outside testing. Submit samples to the appropriate labs for testing Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets. Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes. Uses the purchasing system to procure laboratory supplies. Provide status updates to QC management and other departments regarding the submission of samples. Maintain a safe work environment by following standards and procedures and complying with legal regulations. Lab Equipment Maintains, operates equipment and instruments supporting sample processing. Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals Under close supervision, learns to troubleshoot basic instrument problems Investigations Escalates any trends/events to the QC Lab Manager. Escalates any sample and reference standard documentation issues to the QC Lab Manager. With guidance, participates in OOS/OOT/NOE and other investigations. Assists, as and when needed, scientists working in the laboratory. May assist in drafting, editing, and reviewing SOPs. Training Maintains assigned training records current and in-compliance. May assist in the training of laboratory staff. Compliance Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs. Follows internal processes related to controlled substances. Safety Follows EH&S procedures to ensure a safe work environment. Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS. Education & Experience College graduate, preferably in a Science related field Laboratory experience related to sample management preferred. Knowledge Basic knowledge of sample management in a laboratory environment Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS Competency in Microsoft Office Suite Proficiency with computer savvy Skills & Abilities Ability to display and analyze data in a logical manner Good verbal and written communication skills as well as good computer skills Attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to take initiative, set priorities and follow through on assignments Physical Requirements Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals Must occasionally lift and/or move up to 15-25 lbs. Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods

Job Description The Senior Maintenance Technician will lead maintenance activities in a GMP-regulated pharmaceutical manufacturing environment, ensuring reliable operation of production and facility systems. This role focuses on equipment uptime, preventive maintenance, troubleshooting, and continuous improvement of utilities and process equipment-including tablet presses, granulation systems, and HVAC systems supporting cleanroom operations. Key Responsibilities Perform and oversee preventive, predictive, and corrective maintenance on pharmaceutical manufacturing and facility equipment. Lead troubleshooting and repair efforts on tablet presses, granulators, blenders, fluid bed dryers, coating machines, and other process equipment. Maintain and repair facility utilities such as HVAC systems, compressed air, purified water, steam, chilled water, and vacuum systems. Support calibration and mechanical integrity programs to ensure GMP compliance. Collaborate with Production, Engineering, and Quality departments to minimize downtime and ensure regulatory requirements are met. Review and update maintenance SOPs, work orders, and documentation in accordance with cGMP and FDA standards. Train and mentor junior technicians and provide technical guidance during shifts or project work. Participate in capital projects, equipment installation, and commissioning/qualification activities (IQ/OQ/PQ). Identify and implement process improvements to increase reliability and reduce maintenance costs. Support environmental monitoring and cleanroom operation standards through proper maintenance of HVAC and filtration systems. Qualifications Education: Associate's or Bachelor's degree in Mechanical, Electrical, or Industrial Engineering (or equivalent technical discipline) preferred. Experience: Minimum 5-8 years in a maintenance or engineering role within a pharmaceutical, biotech, or GMP manufacturing environment. Strong hands-on experience with tablet compression, granulation, and packaging equipment. Working knowledge of HVAC systems, cleanroom environments, and associated regulatory requirements (ISO 14644, cGMP). Familiarity with CMMS systems (e.g.,, BMRAM, Maximo, SAP PM) and maintenance documentation practices. Strong understanding of electrical, mechanical, and pneumatic systems. Excellent problem-solving, communication, and leadership skills. Preferred Skills Knowledge of PLCs and control systems troubleshooting. Experience with aseptic or sterile manufacturing utilities. Understanding of 21 CFR Part 11 and data integrity principles. Root cause analysis and reliability-centered maintenance experience.

Reliability Technician / Mechanic Full Time NY-Chestnut Ridge Site, Chestnut Ridge, NY, US The Pharmaceutical Maintenance Mechanic II performs facility reliability maintenance activities in accordance with approved procedures requiring limited supervision. Proficient at analyzing and troubleshooting the root cause of facility, manufacturing and packaging equipment problems. Implements effective preventive and/or corrective maintenance repairs to provide increased reliability. Identifies maintenance improvements that increase efficiency, throughput, and quality. May train others in setting up equipment. Identifies and solves complex problems. Understands the practical application to problems and situations ordinarily encountered and makes decisions that require choosing from several options. Knowledge Has a wide range of technical skills and operational knowledge in procedures, techniques, tools, materials and/or needed equipment. Understands the practical applications to problems and situations ordinarily encountered. Fully knowledgeable of cGMP regulations and processes. Knowledge of equipment capabilities and the ability to train others. Knowledge of processes described in SOPs, where to find and how to use SOPs, and have the ability to train others in relevant SOPs and documentation. Skills & Abilities Qualified with appropriate certifications, as required, and demonstrates competence in equipment maintenance, repair and set-up. Ability to troubleshoot independently. Ability to assess and perform PM tasks and train others in this area. Ability to read schematics, technical drawings, and blueprints. Interfaces with external vendors and service providers. May be required to be proficient in troubleshooting & repair in 4 or more of the following areas: Electrical Hydraulics Pneumatics Mechanical PLC's Proficient in following areas: Ability to read and follow blueprints and engineered drawings. Ability to use the BMS (Bldg. Management System) for HVAC. Specialized in at least 4 of the following 5 areas: Utility - purified water systems, compressed air, boiler, chilled water, electrical distribution, product dust collection systems. Building Maintenance - sewers, electronic card readers (when applicable), lighting. Fire suppression systems. HVAC competence and certification, as required. General building & grounds maintenance. Basic math, writing skills, problem solving. Basic computer skills. Ability to use hand tools. Control Precision - ability to quickly and repeatedly adjust the controls of a machine to exact positions. Education & Experience General A High School Diploma or equivalent is required. Level 3 Tech Seven years related experience and certification in assigned area(s), as required. ACCP-Level II Certification or equivalent experience This position is a 2nd shift role. Hours will be 3 pm to 11.30 pm

Job Description The Chemist II, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment. Detects, conducts, and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains less senior staff. All incumbents are responsible for following applicable Division & Company policies and procedures. KEY ACCOUNTABILITIES Analysis & Testing Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses Reviews and approves laboratory test data and documentation for completeness and compliance Is alert to and detects abnormalities during performances of tests and reviews. Elevates abnormalities to Supervisor Performs lab methods transfer and participate in method validation/verification studies Lab Equipment Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals Troubleshoots instrument/chromatography problems and identifies improvements/CAPAs Investigations Detects, conducts and reports on OOS/OOT/NOE and other investigations Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action Writes, edits and reviews SOPs and laboratory investigations Training Maintains assigned training records current and in-compliance Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures Compliance Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs Follows internal processes related to controlled substances Safety Follows EH&S procedures to ensure a safe work environment Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS QUALIFICATIONS Education & Experience Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years' relevant analytical laboratory experience OR Master's Degree in above disciplines with 2+ years' relevant analytical lab experience Knowledge Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS Has demonstrated competence in conducting chemical analyses Strong knowledge of wet chemistry techniques Competency in Microsoft Office Suite Skills & Abilities Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management Ability to display and analyze data in a logical manner Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information Ability to display and analyze data in a logical manner Strong verbal and written communication skills as well as good computer skills Strong attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to coach less senior staff and develop laboratory skills and ability Ability to take initiative, set priorities and follow through on assignments

Strides Pharma Inc. is seeking an experienced and detail-oriented Analytical Quality Assurance Supervisor to lead our AQA operations in Chestnut Ridge, NY. The AQA Supervisor will be responsible for overseeing the review and approval of analytical data, ensuring compliance with cGMP regulations, and supporting product release and regulatory submissions. This role will collaborate cross-functionally with the Quality Control, Regulatory Affairs, and Manufacturing departments to maintain high standards of product quality and integrity. Responsibilities Manage all Analytical and Quality Control (QC) activities to ensure compliance with cGMP, FDA, EMA, and ICH guidelines. Lead a team of data reviewers, ensuring accurate, complete, and timely review of raw data, analytical results, and laboratory documentation. Supervise the Stability Program and Coordinator, including protocol approval, sample pull scheduling, data review, and reporting. Ensure analytical data integrity through implementation and oversight of robust review processes and audit trails. Collaborate with QC, QA, and R\&D departments to support method validations, transfers, and investigations. Review and approve analytical documentation such as CoAs, method validation/verification protocols and reports, and stability summaries. Lead or support investigations into out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents. Support regulatory inspections and internal/external audits, providing documentation and subject matter expertise. Drive continuous improvement initiatives in QA/QC processes and systems to ensure operational excellence and regulatory readiness. Mentor, coach, and develop the AQA team to build a high-performing quality organization Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency. Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst's notebooks. Review/Approve SOP's, procedures and monographs for the QC Group as needed. Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums. Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP's. Evaluate potential candidates for QA; performance evaluation of direct reports. Coordinate data review for analytical tests, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. Qualifications Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field (Master's or Ph.D. preferred) Minimum of 10 years of experience in pharmaceutical analytical quality assurance or quality control Proven leadership or supervisory experience in a GMP-regulated environment Experience with analytical instrumentation (HPLC, GC, UV, IR, etc.) and associated data review Demonstrated management and leadership experience with strong interpersonal and influencing skills. Strong understanding of FDA regulations, cGMP, ICH guidelines, USP/EP compendia Knowledge of pharmaceutical manufacturing processes and laboratory practices Familiarity with regulatory submission requirements (ANDA, NDA, etc.) Proficiency with laboratory software and documentation systems (e.g., Empower, LIMS, TrackWise) Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values; benefits organization through outside activities; supports affirmative action and respects diversity. Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others. Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates' activities; is available to staff; provides regular performance feedback; develops subordinates' skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills. Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality. Demonstrated flexibility in carrying out varied assignments in a high quality work environment. Excellent written and oral communications skills with a strong emphasis on organizational capabilities. Excellent analytical thinking and problem-solving skills Strong attention to detail with a commitment to quality and compliance Effective leadership, team management, and interpersonal communication Ability to prioritize and manage multiple tasks in a fast-paced environment Proficient in technical writing and reviewing complex data and reports Physical Requirements Ability to sit or stand for extended periods Occasionally lift up to 25 pounds Use of personal protective equipment (PPE) as required in laboratory or production areas Ability to work in office, laboratory, and manufacturing settings as needed The work environment is representative of a group laboratory environment.

Job Description The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 1st shift operations, 7:00am to 3:30pm. This role ensures that all production operations comply with cGMP, safety standards, and production schedules. The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment. Oversees and coordinates Manufacturing and Packaging operations. Responsibilities Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP's, and regulatory requirements (FDA, etc.). Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts. Ensure timely execution of production schedules. Monitors manufacturing and packaging processes to ensure schedule is met within standards. Review and complete shift documentation, including batch documentation, logbooks, etc. Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift. Assist in determining and implementing CAPA. Provide training, guidance, and performance feedback for shift employees. Ensure training requirements are met. Support employee development and cross-training. Executes procedures to complete tasks in a compliant and safe manner. Continuous Improvement Captures and reports metrics; troubleshoots downtime to increase operational efficiency. Lead or participate in Continuous Improvement projects. Troubleshoots and resolves process issues. Issues & Deviations Performs defect evaluations and initiates production events. Identifies, reports, and suggests resolutions for processing related issues. Assists in the investigation of unplanned deviations. Teamwork and collaboration Provides priorities for the off-shift operations, focusing resources on priority products. Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues. Continuous Training Ensures personnel are current with training requirements. Stays current on SOPs and cGMPs. Continuous Safety & Compliance Contribute to safety audits. Ensures out manufacturing/packaging activities safely, as required, on a daily basis. Follows all safety and compliance procedures and participates in required training. Adheres to all cGMP compliance/regulatory mandates and quality requirements. Participate in safety teams, start-up discussions, incident debriefs, etc. Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies. Misc Other related duties as assigned to meet departmental and Company objectives. Education & Experience Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related discipline preferred; relevant experience my substitute. Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging. Knowledge Thorough knowledge of cGMP and FDA regulations. Thorough knowledge of manufacturing and packaging operations. Skills & Abilities Demonstrated leadership, communication, and decision-making skills. Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards. Ability to analyze metrics and troubleshoot downtime. Effectively interfaces with Quality Assurance to inform of deviations or other line issues. Demonstrates the ability to work in collaboration with others as a part of a team. Ability to lead in Continuous Improvement projects. Posses technical writing skills.

Job Description The Entry-Level Associate, Quality Assurance supports the Quality Management System (QMS) and documentation processes at the Chestnut Ridge site. This role is designed for individuals beginning their career in pharmaceutical quality assurance and provides hands-on experience in maintaining compliance and supporting documentation workflows in a regulated environment. Roles and Responsibilities Assist in organizing and maintaining QMS documentation including SOPs, CAPAs, deviations, and complaints. Support the preparation and tracking of quality metrics and trending reports. Help coordinate internal audits and document audit responses. Participate in documenting product quality complaints and adverse event records. Aid in digitizing logbooks and checklists using electronic systems. Collaborate with cross-functional teams to ensure timely and accurate documentation updates. Provide administrative support for change control processes and quality-related meetings. Assist in preparing documentation for regulatory inspections and external audits. Maintain document control systems and ensure timely review and archival of QA records. Support training documentation and tracking for QA-related procedures. Help with data entry and analysis for quality reports using basic statistical tools. Monitor document lifecycle and ensure version control compliance. Participate in continuous improvement initiatives related to documentation and QMS processes. Education & Experience Required Education: Bachelor's degree in Pharmaceutical Sciences or a related field. Preferred Education: Master's degree is a plus. Experience: 1-3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable). Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred. Physical Requirements On-site role at Chestnut Ridge, NY. Standard work hours: 8 AM to 5 PM. No travel required. No lifting or driving responsibilities. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

The Senior Maintenance Technician will lead maintenance activities in a GMP-regulated pharmaceutical manufacturing environment, ensuring reliable operation of production and facility systems. This role focuses on equipment uptime, preventive maintenance, troubleshooting, and continuous improvement of utilities and process equipment-including tablet presses, granulation systems, and HVAC systems supporting cleanroom operations. Key Responsibilities Perform and oversee preventive, predictive, and corrective maintenance on pharmaceutical manufacturing and facility equipment. Lead troubleshooting and repair efforts on tablet presses, granulators, blenders, fluid bed dryers, coating machines, and other process equipment. Maintain and repair facility utilities such as HVAC systems, compressed air, purified water, steam, chilled water, and vacuum systems. Support calibration and mechanical integrity programs to ensure GMP compliance. Collaborate with Production, Engineering, and Quality departments to minimize downtime and ensure regulatory requirements are met. Review and update maintenance SOPs, work orders, and documentation in accordance with cGMP and FDA standards. Train and mentor junior technicians and provide technical guidance during shifts or project work. Participate in capital projects, equipment installation, and commissioning/qualification activities (IQ/OQ/PQ). Identify and implement process improvements to increase reliability and reduce maintenance costs. Support environmental monitoring and cleanroom operation standards through proper maintenance of HVAC and filtration systems. Qualifications Education: Associate's or Bachelor's degree in Mechanical, Electrical, or Industrial Engineering (or equivalent technical discipline) preferred. Experience: Minimum 5-8 years in a maintenance or engineering role within a pharmaceutical, biotech, or GMP manufacturing environment. Strong hands-on experience with tablet compression, granulation, and packaging equipment. Working knowledge of HVAC systems, cleanroom environments, and associated regulatory requirements (ISO 14644, cGMP). Familiarity with CMMS systems (e.g.,, BMRAM, Maximo, SAP PM) and maintenance documentation practices. Strong understanding of electrical, mechanical, and pneumatic systems. Excellent problem-solving, communication, and leadership skills. Preferred Skills Knowledge of PLCs and control systems troubleshooting. Experience with aseptic or sterile manufacturing utilities. Understanding of 21 CFR Part 11 and data integrity principles. Root cause analysis and reliability-centered maintenance experience.

Reliability Technician / Mechanic Full Time NY-Chestnut Ridge Site, Chestnut Ridge, NY, US The Pharmaceutical Maintenance Mechanic II performs facility reliability maintenance activities in accordance with approved procedures requiring limited supervision. Proficient at analyzing and troubleshooting the root cause of facility, manufacturing and packaging equipment problems. Implements effective preventive and/or corrective maintenance repairs to provide increased reliability. Identifies maintenance improvements that increase efficiency, throughput, and quality. May train others in setting up equipment. Identifies and solves complex problems. Understands the practical application to problems and situations ordinarily encountered and makes decisions that require choosing from several options. Knowledge Has a wide range of technical skills and operational knowledge in procedures, techniques, tools, materials and/or needed equipment. Understands the practical applications to problems and situations ordinarily encountered. Fully knowledgeable of cGMP regulations and processes. Knowledge of equipment capabilities and the ability to train others. Knowledge of processes described in SOPs, where to find and how to use SOPs, and have the ability to train others in relevant SOPs and documentation. Skills & Abilities Qualified with appropriate certifications, as required, and demonstrates competence in equipment maintenance, repair and set-up. Ability to troubleshoot independently. Ability to assess and perform PM tasks and train others in this area. Ability to read schematics, technical drawings, and blueprints. Interfaces with external vendors and service providers. May be required to be proficient in troubleshooting & repair in 4 or more of the following areas: Electrical Hydraulics Pneumatics Mechanical PLC's Proficient in following areas: Ability to read and follow blueprints and engineered drawings. Ability to use the BMS (Bldg. Management System) for HVAC. Specialized in at least 4 of the following 5 areas: Utility - purified water systems, compressed air, boiler, chilled water, electrical distribution, product dust collection systems. Building Maintenance - sewers, electronic card readers (when applicable), lighting. Fire suppression systems. HVAC competence and certification, as required. General building & grounds maintenance. Basic math, writing skills, problem solving. Basic computer skills. Ability to use hand tools. Control Precision - ability to quickly and repeatedly adjust the controls of a machine to exact positions. Education & Experience General A High School Diploma or equivalent is required. Level 3 Tech Seven years related experience and certification in assigned area(s), as required. ACCP-Level II Certification or equivalent experience This position is a 2nd shift role. Hours will be 3 pm to 11.30 pm

Job Description QC Lab Sample Coordinator The Lab Sample Coordinator, under direct supervision, performs QC laboratory sample receipt, processing, distribution for testing, storage and reconciliation through to disposal. Performs reference standards, chromatographic columns receipt, distribution, monitoring. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Accountability & Responsibilities Sample Management Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage Performs QC sample reconciliation and disposal Tracks inventory of product samples, stability samples, and test materials in the lab Uses laboratory software for sample, reference standard, chromatographic column management Verifies accuracy of labeling/documentation provided with samples Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area. Send samples for outside testing. Submit samples to the appropriate labs for testing Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets. Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes. Uses the purchasing system to procure laboratory supplies. Provide status updates to QC management and other departments regarding the submission of samples. Maintain a safe work environment by following standards and procedures and complying with legal regulations. Lab Equipment Maintains, operates equipment and instruments supporting sample processing. Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals Under close supervision, learns to troubleshoot basic instrument problems Investigations Escalates any trends/events to the QC Lab Manager. Escalates any sample and reference standard documentation issues to the QC Lab Manager. With guidance, participates in OOS/OOT/NOE and other investigations. Assists, as and when needed, scientists working in the laboratory. May assist in drafting, editing, and reviewing SOPs. Training Maintains assigned training records current and in-compliance. May assist in the training of laboratory staff. Compliance Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs. Follows internal processes related to controlled substances. Safety Follows EH&S procedures to ensure a safe work environment. Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS. Education & Experience College graduate, preferably in a Science related field Laboratory experience related to sample management preferred. Knowledge Basic knowledge of sample management in a laboratory environment Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS Competency in Microsoft Office Suite Proficiency with computer savvy Skills & Abilities Ability to display and analyze data in a logical manner Good verbal and written communication skills as well as good computer skills Attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to take initiative, set priorities and follow through on assignments Physical Requirements Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals Must occasionally lift and/or move up to 15-25 lbs. Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods

The Chemist II, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical and chemical analyses (including complex analyses) using all equipment. Detects, conducts, and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Trains less senior staff. All incumbents are responsible for following applicable Division & Company policies and procedures. KEY ACCOUNTABILITIES Analysis & Testing Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses Reviews and approves laboratory test data and documentation for completeness and compliance Is alert to and detects abnormalities during performances of tests and reviews. Elevates abnormalities to Supervisor Performs lab methods transfer and participate in method validation/verification studies Lab Equipment Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals Troubleshoots instrument/chromatography problems and identifies improvements/CAPAs Investigations Detects, conducts and reports on OOS/OOT/NOE and other investigations Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action Writes, edits and reviews SOPs and laboratory investigations Training Maintains assigned training records current and in-compliance Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures Compliance Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs Follows internal processes related to controlled substances Safety Follows EH&S procedures to ensure a safe work environment Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS QUALIFICATIONS Education & Experience Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years' relevant analytical laboratory experience OR Master's Degree in above disciplines with 2+ years' relevant analytical lab experience Knowledge Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS Has demonstrated competence in conducting chemical analyses Strong knowledge of wet chemistry techniques Competency in Microsoft Office Suite Skills & Abilities Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management Ability to display and analyze data in a logical manner Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information Ability to display and analyze data in a logical manner Strong verbal and written communication skills as well as good computer skills Strong attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to coach less senior staff and develop laboratory skills and ability Ability to take initiative, set priorities and follow through on assignments

The Manufacturing Operator III - Granulation performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. Applies skills and knowledge to recognize issues and to increase efficiency, throughput and quality. Proactively identifies and resolves complex problems where considerable judgment is required in choosing among multiple options. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations. Responsible for the safe and efficient execution of job duties. May serve as back-up to the Senior Manufacturing Technician. Manufacturing Operations work unit at the various Strides locations listed above Accountability / Responsibilities Manufacturing Process Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, mixing, granulating, drying, milling, blending, potent compound, etc. Meets requirements for use of manufacturing equipment and other commonly used equipment per SOPs. Executes written SOPs to ensure the purity of materials involved in the manufacturing process. Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs. Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production. Cleans manufacturing equipment and facilities according to established SOPs. Executes machine change-overs from batch to batch. Completes a variety of assignments independently based on established procedures. Identifies process improvements that drive increased efficiency, throughput and quality. May sample batches, including validation batches, for quality testing. Executes required in-process product quality checks and documents accurately. Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debriefing sessions to understand the reasons why and what needs to be corrected moving forward. Documentation Completes documentation associated with manufacturing processes (e.g. batch record, protocol, and logbooks and E-logs) with detail and accuracy. Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets. Verifies the manufacturing process on BPR in an accurate and timely manner. Provides status updates and operational challenges. Continuous Improvement Proactively identifies and troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations. Typically participates in Continuous Improvement projects of a higher scope and complexity. Safety & Compliance Carries out processing/manufacturing activities safely, as required, on a daily basis. Follows all safety and compliance procedures and participates in required training. Adheres to all cGMP compliance/regulatory mandates and quality requirements. Participates in safety teams, start-up discussions, and incident debriefs, etc. Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies. Maintains a clean, organized work area. Continuous Training Conforms to all training requirements, including company required and machine specific training. May become a certified trainer and provide mentoring and training. Teamwork and collaboration Exhibits team work and motivates others to achieve project objectives. Collaborates within own work unit and with those from other departments outside of work unit and/or with external vendors/suppliers. Education & Experience HS diploma or equivalent at minimum, with 2-3 years' related experience* Forklift certification may be required for blending and granulation. Knowledge e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Knowledge of cGMPs. Basic math, reading, legible writing skills, and problem solving abilities. Has thorough knowledge and skills in the processes noted below. Has a wide range of technical skills and operational knowledge. Understands the practical applications to problems and situations ordinarily encountered. Skills & Abilities Proficient in running machinery. Proficient in (Master Clean/Surface clean) equipment cleaning. Proficient in setting up machinery. Proficient in trouble shooting. Ability to become a certified trainer and provide certified training in one process. Ability to effectively interface with other departments if senior level (4th level) isn't available. Ability to participate in Continuous Improvement projects. Posesses capability to be Qualified in multiple locations within the Granulation department and/or cross trained in Blending (where applicable) and at least one of the following manufacturing processes: Granulation Compression Coating Encapsulation Potent Compound Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly. Attendance/Punctuality - Is consistently at work and on time; Arrives at meetings and appointments on time. Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Comply with all Company policies and procedures. Comply with all Company safety rules and regulations. Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. Must be able to stand for long periods of time (up to 12 hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes. Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects. Vision - ability to see details at close range (within a few feet of the observer). Hearing - ability to detect or tell the differences between sounds that vary in pitch and loudness. Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.

Job Description Strides Pharma Inc. is seeking an experienced and detail-oriented Analytical Quality Assurance Supervisor to lead our AQA operations in Chestnut Ridge, NY. The AQA Supervisor will be responsible for overseeing the review and approval of analytical data, ensuring compliance with cGMP regulations, and supporting product release and regulatory submissions. This role will collaborate cross-functionally with the Quality Control, Regulatory Affairs, and Manufacturing departments to maintain high standards of product quality and integrity. Responsibilities Manage all Analytical and Quality Control (QC) activities to ensure compliance with cGMP, FDA, EMA, and ICH guidelines. Lead a team of data reviewers, ensuring accurate, complete, and timely review of raw data, analytical results, and laboratory documentation. Supervise the Stability Program and Coordinator, including protocol approval, sample pull scheduling, data review, and reporting. Ensure analytical data integrity through implementation and oversight of robust review processes and audit trails. Collaborate with QC, QA, and R &D departments to support method validations, transfers, and investigations. Review and approve analytical documentation such as CoAs, method validation/verification protocols and reports, and stability summaries. Lead or support investigations into out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents. Support regulatory inspections and internal/external audits, providing documentation and subject matter expertise. Drive continuous improvement initiatives in QA/QC processes and systems to ensure operational excellence and regulatory readiness. Mentor, coach, and develop the AQA team to build a high-performing quality organization Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency. Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst's notebooks. Review/Approve SOP's, procedures and monographs for the QC Group as needed. Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums. Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP's. Evaluate potential candidates for QA; performance evaluation of direct reports. Coordinate data review for analytical tests, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. Qualifications Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field (Master's or Ph.D. preferred) Minimum of 10 years of experience in pharmaceutical analytical quality assurance or quality control Proven leadership or supervisory experience in a GMP-regulated environment Experience with analytical instrumentation (HPLC, GC, UV, IR, etc.) and associated data review Demonstrated management and leadership experience with strong interpersonal and influencing skills. Strong understanding of FDA regulations, cGMP, ICH guidelines, USP/EP compendia Knowledge of pharmaceutical manufacturing processes and laboratory practices Familiarity with regulatory submission requirements (ANDA, NDA, etc.) Proficiency with laboratory software and documentation systems (e.g., Empower, LIMS, TrackWise) Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values; benefits organization through outside activities; supports affirmative action and respects diversity. Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others. Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates' activities; is available to staff; provides regular performance feedback; develops subordinates' skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills. Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality. Demonstrated flexibility in carrying out varied assignments in a high quality work environment. Excellent written and oral communications skills with a strong emphasis on organizational capabilities. Excellent analytical thinking and problem-solving skills Strong attention to detail with a commitment to quality and compliance Effective leadership, team management, and interpersonal communication Ability to prioritize and manage multiple tasks in a fast-paced environment Proficient in technical writing and reviewing complex data and reports Physical Requirements Ability to sit or stand for extended periods Occasionally lift up to 25 pounds Use of personal protective equipment (PPE) as required in laboratory or production areas Ability to work in office, laboratory, and manufacturing settings as needed The work environment is representative of a group laboratory environment.

Associate, Quality Assurance (Sampling) Department: Quality Assurance The Entry-Level Associate, Quality Assurance supports the sampling activities and shop floor quality operations at the Chestnut Ridge site. Roles and Responsibilities Raw Material Sampler Key Responsibilities: Cleaning/Approving: Cleaning, approving and preparing the sampling room and utensils for raw material sampling according to established procedures. Inspection of Materials: Visually inspecting raw materials and packaging components for any damage, defects, or non-conformities before and during sampling. Sampling: Collecting samples of incoming raw materials and packaging components from various vendors, warehouses or storage locations according to established GMP (Good Manufacturing Practice) and quality control procedures. Documentation and Labeling: Accurately labeling and documenting samples with all relevant information (e.g., lot number, including sample details, date, time, and any relevant observations) and maintaining thorough records of all sampling activities. Sample Handling and Delivery: Ensuring samples are stored correctly and securely and maintaining their integrity until they are delivered to the appropriate laboratories for testing (e.g., microbiology, chemistry, packaging). Testing: Submitting samples to the laboratory for testing and analysis, often coordinating with lab personnel. Record Keeping: Maintaining detailed records of all sampling activities, including test results and any deviations or discrepancies. Communication: Effectively communicating with warehouse, procurement, and laboratory teams to coordinate sampling schedules, report discrepancies, and ensure a smooth workflow. Inventory Management: Assisting with inventory tracking and the organization of raw materials in storage areas. Safety Compliance: Following all safety protocols and procedures to prevent contamination and ensure a safe working environment. Maintaining a Clean Work Environment: Ensuring the cleanliness and hygiene of sampling areas and equipment, especially in controlled environments. Calibration and Maintenance: Calibrating or verifying the calibration of sampling instruments and maintaining supplies as needed. Troubleshooting and Problem-Solving: Identifying and reporting any quality variances or issues with incoming materials and assisting in investigations of raw material complaints. Compliance: Adhering strictly to all relevant safety procedures, regulatory requirements (like GMP), and company procedures to prevent contamination and ensure accurate results Education & Experience Required Education: High school or Bachelor's degree in Pharmaceutical Sciences or a related field. Experience: 1-3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable). Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred. Physical Requirements On-site role at Pearl River, NY. Standard work hours: 7 AM to 4 PM. No travel required. Able to lift 50 lbs.

The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 1st shift operations, 7:00am to 3:30pm. This role ensures that all production operations comply with cGMP, safety standards, and production schedules. The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment. Oversees and coordinates Manufacturing and Packaging operations. Responsibilities Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP's, and regulatory requirements (FDA, etc.). Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts. Ensure timely execution of production schedules. Monitors manufacturing and packaging processes to ensure schedule is met within standards. Review and complete shift documentation, including batch documentation, logbooks, etc. Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift. Assist in determining and implementing CAPA. Provide training, guidance, and performance feedback for shift employees. Ensure training requirements are met. Support employee development and cross-training. Executes procedures to complete tasks in a compliant and safe manner. Continuous Improvement Captures and reports metrics; troubleshoots downtime to increase operational efficiency. Lead or participate in Continuous Improvement projects. Troubleshoots and resolves process issues. Issues & Deviations Performs defect evaluations and initiates production events. Identifies, reports, and suggests resolutions for processing related issues. Assists in the investigation of unplanned deviations. Teamwork and collaboration Provides priorities for the off-shift operations, focusing resources on priority products. Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues. Continuous Training Ensures personnel are current with training requirements. Stays current on SOPs and cGMPs. Continuous Safety & Compliance Contribute to safety audits. Ensures out manufacturing/packaging activities safely, as required, on a daily basis. Follows all safety and compliance procedures and participates in required training. Adheres to all cGMP compliance/regulatory mandates and quality requirements. Participate in safety teams, start-up discussions, incident debriefs, etc. Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies. Misc Other related duties as assigned to meet departmental and Company objectives. Education & Experience Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related discipline preferred; relevant experience my substitute. Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging. Knowledge Thorough knowledge of cGMP and FDA regulations. Thorough knowledge of manufacturing and packaging operations. Skills & Abilities Demonstrated leadership, communication, and decision-making skills. Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards. Ability to analyze metrics and troubleshoot downtime. Effectively interfaces with Quality Assurance to inform of deviations or other line issues. Demonstrates the ability to work in collaboration with others as a part of a team. Ability to lead in Continuous Improvement projects. Posses technical writing skills.

The Entry-Level Associate, Quality Assurance supports the Quality Management System (QMS) and documentation processes at the Chestnut Ridge site. This role is designed for individuals beginning their career in pharmaceutical quality assurance and provides hands-on experience in maintaining compliance and supporting documentation workflows in a regulated environment. Roles and Responsibilities Assist in organizing and maintaining QMS documentation including SOPs, CAPAs, deviations, and complaints. Support the preparation and tracking of quality metrics and trending reports. Help coordinate internal audits and document audit responses. Participate in documenting product quality complaints and adverse event records. Aid in digitizing logbooks and checklists using electronic systems. Collaborate with cross-functional teams to ensure timely and accurate documentation updates. Provide administrative support for change control processes and quality-related meetings. Assist in preparing documentation for regulatory inspections and external audits. Maintain document control systems and ensure timely review and archival of QA records. Support training documentation and tracking for QA-related procedures. Help with data entry and analysis for quality reports using basic statistical tools. Monitor document lifecycle and ensure version control compliance. Participate in continuous improvement initiatives related to documentation and QMS processes. Education & Experience Required Education: Bachelor's degree in Pharmaceutical Sciences or a related field. Preferred Education: Master's degree is a plus. Experience: 1-3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable). Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred. Physical Requirements On-site role at Chestnut Ridge, NY. Standard work hours: 8 AM to 5 PM. No travel required. No lifting or driving responsibilities. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.