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Job Description Job Summary - The Manufacturing Operator III 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. Key Accountabilities - Accountability / Responsibilities Manufacturing Process • Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing, potent compound, etc. Meets requirements for use of manufacturing equipment and other commonly used equipment per SOPs., • This position is 2nd shift fluid bed dryer operator. A depth of knowledge in fluid bed dryer operations is required to be able to operate and troubleshoot fluid bed dryer operations during 2nd shift (3:30pm-11:45pm)., • 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., • Completes documentation associated with manufacturing processes (e.g. batch record, protocol, and logbooks) 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., • Proactively identifies and troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations., • 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., • Conforms to all training requirements, including company required and machine specific training., • Exhibits team work and motivates others to achieve project objectives., • HS diploma or equivalent at minimum, with 2+ years’ related experience*, • 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., • Proficient in operating Fluid Bed Dryers or equivalent., • 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., • Qualified in both Weighing and 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. Physical Requirements • 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 Job Summary - 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., • 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., • Proactively identifies and troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations., • 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., • Conforms to all training requirements, including company required and machine specific training., • Exhibits team work and motivates others to achieve project objectives., • HS diploma or equivalent at minimum, with 2-3 years’ related experience* 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., • 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. 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 Job Summary 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., • Conducts verification of line/equipment cleaning and documents per SOP., • Executes procedures used to clean pharmaceutical packaging equipment and facilities., • Captures and reports metrics; troubleshoots downtime in order to increase operational efficiency., • Lead or participate in Continuous Improvement projects., • Performs defect evaluations and initiates production event logs., • Identifies, reports, and suggests resolutions for processing related issues., • Communicates and coordinates change-overs and other equipment downtime issues to Reliability Technicians., • Is qualified as a certified trainer and provides training to less senior operators., • 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., • High school diploma or equivalent., • Thorough knowledge of cGMP regulations and processes., • 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., • 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 QC Lab Sample Coordinator Summary 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., • 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, • 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., • Maintains assigned training records current and in-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 EH&S procedures to ensure a safe work environment., • College graduate, preferably in a Science related field, • 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, • 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, • 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

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