Quality Inspector jobs at West Pharmaceutical Services

Training for this position will be Monday - Friday Day shift. Fourth Quarter 2025 or First Quarter 2026 this position will change to a 2-2-3-2 12 hour day shift. At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. **Job Summary** **Schedule- 12 hour day shift** In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained. **Essential Duties and Responsibilities** + Review and approval of metrology reports, where appropriate, for batch release and validation purposes + New product validation, analysis and reporting. + Quality support to Engineering and Production Departments. + Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems. + Liaise with customers and suppliers on new and existing projects. + Receiving and inspection of incoming goods and materials. + Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications. + Maintain good communications both internally and externally. + Ensures that all metrology equipment is correctly calibrated. + Assists shift personnel with quality issues and/or measurement techniques. + Assists in problem resolution with customers. + Perform periodic audits as requested and completes necessary documentation. + Archives quality records, samples and log procedures. + Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures. + Batch paperwork review and final decision to release product for shipment. **Additional Responsibilities** + Provide a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards. + Maintain a clean, orderly, and safe workstation and environment at all times. + Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules. + Exhibit regular, reliable, and punctual attendance. + Perform other duties as assigned based on business needs. + Keep current with new GMP compliance guidance and internal QA procedures + Support new GMP compliance guidance and Data Integrity initiatives \#LI-CS1 #LI-Onsite **Education** + High School Diploma or GED Required + Preferred Associates degree in Metrology or QA; or 3 years' on the job experience in a plastics manufacturing environment **Work Experience** + 3 years of job-related experience; in QA/QC and the use of measuring equipment. **Preferred Knowledge, Skills and Abilities** + Able to be aware of all relevant standard operating procedures as per Company policy + Support and contribute to Lean Sigma programs and activities towards delivery of the set target + Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude + Willingness to learn new and review new analytical techniques + Meet individual and departmental goals as required **Travel Requirements** 5%: Up to 13 business days per year **Physical Requirements** Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. **Additional Requirements** + Ability to learn, understand, and remember normal tasks. + Ability to hear, speak, and understand conversation in English in a normal tone of voice. + Must maintain the ability to work well with others in a variety of situations. + Must be able to multi-task, work under time constraints, problem solve, and prioritize. + Read and interpret data, information and documents + Work under deadlines with constant interruptions West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening. \#LI-ME1

GxP Quality Auditor / Senior Quality Lead Employment Type: Full-Time, On-Site Salary Range: $87,780 - $145,307/year A leading life sciences organization is seeking a GxP Quality Auditor / Senior Quality Lead to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity. Position Summary The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment. Key Responsibilities Coordinate between site and global teams to align SOPs and bracketing strategy Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements Develop and defend bracketing justification for multiple manufacturing lines and isolators Facilitate governance meetings, escalate risks, and report status to leadership Review and approve protocol templates, summaries, and reports for finalization Qualifications Bachelor's degree in a scientific or industry-related field Minimum 7+ years of experience in pharmaceutical manufacturing or compliance Proven experience developing bracketing and matrixing strategies Strong knowledge of FDA, EMA, and HMRA regulations Familiarity with cGMP and facility/equipment validation requirements Excellent technical writing and communication skills Ability to work full-time on-site in Greenville, NC Why Join This Team? Competitive compensation and performance-based incentives Comprehensive benefits package including medical, dental, vision, and retirement plans Paid time off, holidays, and professional development opportunities Collaborative culture with strong career growth potential

Full-time Description Why You'll Love Working With Us: We believe great benefits shouldn't have to wait. That's why we offer: Day-One Benefits - Enjoy our full benefits package starting your very first day-no waiting period required. 401(k) with Company Match - We invest in your future with a generous 401(k) plan and company contributions to grow your savings faster. Paid Time Off - Recharge and take the time you need with our competitive vacation package, paid holidays and PTO. Tuition Reimbursement - We support your growth. Advance your education and career with our tuition assistance program Summary The Inspector position is responsible for following company ISO Procedure for incoming, in-process and final inspection, calibration of product and material identified as requiring conformance verification. Essential Duties and Responsibilities Inspects product during production for conformance to specification by performing the following duties. Responsible for verifying the conformance of supplied products, where required. Extent of verification is based on the type of received product. Products requiring inspection will be inspected as per plan. Visually examines parts for surface defects such as material shortage, flash, cracks, etc. Works from blueprint drawings, charts, or specifications to check dimensions, squareness, hole locations, surface relationships, finish, material defects, etc. Ensure that all protractors, squares, and combination squares are calibrated to the standards described in work instructions. Approves incoming materials by confirming specifications; conducting visual and measurement test; rejecting and returning unacceptable materials. Approves in-process production by confirming specifications; conducting visual and measurement tests; communicating required adjustments to production supervisor/manufacturing manager. Approves finished products by confirming specifications; conducting visual and measurement tests; returning products to re-work; confirming re-work. Upload pictures and edit them for reports. Documents inspection results by completing reports and logs; summarizing re-work and waste. Keeps measurement equipment operating by following operating instructions; calls for repairs. Maintains safe and healthy work environment by following standards and procedures; complies with legal regulations. Requirements Knowledge, Skills, and Abilities Possess a strong attention to detail. Knowledge of welding is desired. Possess strong communication skills (verbal and written) and interpersonal skills. Possess strong computer skills. Knowledge of MS Word and Excel is desired. Ability to read and interpret blueprints and engineering drawings. Knowledge of measuring equipment such as calipers, durometer testers, gauges, and other metrology tools. Possess strong math skills. Ability to travel to customer or vendor sites as needed. Travel is approx. 5% of duty. Education and Experience High School Diploma or equivalent GED required. Education or training beyond High School strongly desired. Minimum 2 or more years of related experience working in a inspection/manufacturing environment required. Physical/Visual/Mental/ Environmental Factors The demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals to perform the essential functions. 1. Regularly required to sit and use hands and finger dexterity. 2. Occasionally required to stand, walk, stoop, kneel, crouch, and reach with hands and arms. 3. Occasionally required to lift up to 25 pounds. 4. Regularly requires close vision, hearing and talking. 5. Exposure to moderate noise level while in office. 6. Frequently exposed to moving mechanical parts 7. Required to climb ladders as well as climb on top of machinery with use of a harness. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Exact compensation may vary based on skills, experience, and location. To learn more about available benefits, please click ************************************** Salary Description $28.00 - $34.00 P/H

Description Ipsen is a Drug Free Workplace Why You'll Love Working With Us: We believe great benefits shouldn't have to wait. That's why we offer: Day-One Benefits - Enjoy our full benefits package starting your very first day-no waiting period required. 401(k) with Company Match - We invest in your future with a generous 401(k) plan and company contributions to grow your savings faster. Paid Time Off - Recharge and take the time you need with our competitive vacation package, paid holidays and PTO. Tuition Reimbursement - We support your growth. Advance your education and career with our tuition assistance program Summary The Inspector position is responsible for following company ISO Procedure for incoming, in-process and final inspection, calibration of product and material identified as requiring conformance verification. Essential Duties and Responsibilities Inspects product during production for conformance to specification by performing the following duties. Responsible for verifying the conformance of supplied products, where required. Extent of verification is based on the type of received product. Products requiring inspection will be inspected as per plan. Visually examines parts for surface defects such as material shortage, flash, cracks, etc. Works from blueprint drawings, charts, or specifications to check dimensions, squareness, hole locations, surface relationships, finish, material defects, etc. Ensure that all protractors, squares, and combination squares are calibrated to the standards described in work instructions. Approves incoming materials by confirming specifications; conducting visual and measurement test; rejecting and returning unacceptable materials. Approves in-process production by confirming specifications; conducting visual and measurement tests; communicating required adjustments to production supervisor/manufacturing manager. Approves finished products by confirming specifications; conducting visual and measurement tests; returning products to re-work; confirming re-work. Upload pictures and edit them for reports. Documents inspection results by completing reports and logs; summarizing re-work and waste. Keeps measurement equipment operating by following operating instructions; calls for repairs. Maintains safe and healthy work environment by following standards and procedures; complies with legal regulations. Requirements Knowledge, Skills, and Abilities Possess a strong attention to detail. Knowledge of welding is desired. Possess strong communication skills (verbal and written) and interpersonal skills. Possess strong computer skills. Knowledge of MS Word and Excel is desired. Ability to read and interpret blueprints and engineering drawings. Knowledge of measuring equipment such as calipers, durometer testers, gauges, and other metrology tools. Possess strong math skills. Ability to travel to customer or vendor sites as needed. Travel is approx. 5% of duty. Education and Experience High School Diploma or equivalent GED required. Education or training beyond High School strongly desired. Minimum 2 or more years of related experience working in a inspection/manufacturing environment required. Physical/Visual/Mental/ Environmental Factors The demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals to perform the essential functions. 1. Regularly required to sit and use hands and finger dexterity. 2. Occasionally required to stand, walk, stoop, kneel, crouch, and reach with hands and arms. 3. Occasionally required to lift up to 25 pounds. 4. Regularly requires close vision, hearing and talking. 5. Exposure to moderate noise level while in office. 6. Frequently exposed to moving mechanical parts 7. Required to climb ladders as well as climb on top of machinery with use of a harness. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Exact compensation may vary based on skills, experience, and location. To learn more about available benefits, please click ************************************** Salary Description $28.00 - $34.00 P/H

What You've Accomplished You have completed a High School diploma and at least 5 years of related experience. You may have completed an Associate's Degree in a Technical Discipline and at least 2 years of related experience and are ready to join Framatome and help deliver clean, safe energy and advance nuclear technology. Who You Are Your actions, behaviors, and decisions are made in a manner consistent with our Core Values: *************************************************** You may have also acquired the following skills: Knowledge of basic related engineering, quality assurance and quality control standards techniques and criteria. Good verbal and written communication skills and the ability to comprehend and convey technical data. Ability to develop and maintain good interpersonal relationships with all levels of staff and management. Ability to work independently. Good problem identification and problem resolution skills. Good organizational skills. Additional preferred skills: Past or current experience in performing inspections and be able to be certified to ANSI N45.2.6 as a Level II inspector. Must be able to pass practical and written test. Knowledge of 10CFR50 Appendix-B- and NQA-1 Quality Programs. Familiar in the use of common computer software such as Word, Excel in generating documents. Knowledge and application of the fundamental concepts, practices and procedures of particular field of specialization Familiar with standard concepts, practices, and procedures within the quality field. Intermediate computer skills including job specific programs, spreadsheets, word processing Ability to read and understand procedures, specifications and drawings and to evaluate documentation for compliance with design specifications Your Opportunity This full-time role is about making an impact on people's lives and the future of clean energy. You will leverage your skills and experience to be part of an innovative team and make a difference for our customers. As a Quality Inspector in Cranberry Township, PA, you will be part of the proven team in the Quality Performance and Safety Business Line in the Installed Base Business Unit. The Quality Operations Group is responsible for compliance/oversight inspection and surveillance activities related to outage and in-house facilities activities I.A.W. Framatome Quality Assurance Program requirements, Framatome performance and continuous improvement expectations. The Quality Inspector is responsible for activities involving quality assurance and compliance with applicable regulatory, Framatome, and customer requirements. You will perform various types of QC inspections including receiving inspection, in-process and final inspections on electrical, mechanical and visual products at Framatome facilities, supplier shops and customer location. This role conducts physical measurements and tests of components as needed to verify quality characteristics. You must be able to pass Fitness-for-Duty screening and testing for access to nuclear power plants. Your work will include: Conducts oversight and verify products for compliance to procedures. Performs QC inspection duties performing inspections at Framatome facilities in Lynchburg and other locations as needed. Conducts physical measurements and tests of components as needed to verify quality characteristics. Utilizes judgment and experience to identify issues which affect product quality in manufacturing areas. Utilizes judgment and experience to identify procedural and process weaknesses in manufacturing areas. Conducts independent verification of completion of actions reported as complete within the corrective action program. During outage assignments must be able to work 12-hour days 6 days a week. (Including either day or night shifts) Reviews/analyses data and documentation for acceptance of products /processes. Be willing and able to travel and support inspection and oversight activities at US and Foreign utilities during peak outage seasons for weeks at a time. Be competent to perform tasks that may impact on health and safety in the workplace. This position requires up to 25% travel. Together we will enable clean, safe, and economical low-carbon energy to meet the global ambition for a better tomorrow. Who We Are Framatome is an international leader in nuclear energy recognized for its innovative solutions and value-added technologies for the global nuclear fleet. More than 2,000 dedicated U.S. Framatome employees work every day to supply ever cleaner, safer, and more economical low-carbon energy for our communities and world. As well as supporting new nuclear builds, advancing new technology and advancing nuclear energy in the U.S. and abroad. Like you, we want a brighter future. See how the Installed Base Business Unit contributes to this future: **************************************************************** Any employment offer is contingent upon the successful completion of a background investigation and drug screen (as applicable). Your Total Rewards Package The range of base salary for the position is between $24.10 - $31.50 per hour, and may also include annual incentives, performance bonuses and benefits. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies and work location. Framatome offers a broad employee benefits portfolio as a key component of your total rewards. This includes: Multiple medical plans; dental and vision plans; Life and Accidental Death and Dismemberment; long- and short-term disability; optional plans including dependent life, accident, critical illness and hospital indemnity insurance; retirement savings plans (401k) with employer match; paid time off including up to 3 weeks of vacation, 8 days of sick leave, and 13 paid holidays; education reimbursement; adoption assistance; employee assistance programs; opportunities for professional development. Positions within Framatome may require access to proprietary information that is subject to U.S. export control regulations. As such, the Company must ensure that any hires for these job openings fully comply with all US regulations. Foreign national applicants that are citizens or residents of countries not included on the Department of Energy's Generally Authorized Destinations list may not be eligible for immediate need positions. See list here: ************************************************************************************************** Framatome is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Pay Range: $16.50/Hr.- $18.50/Hr. (Commission, shift differential and milage reimbursement options). Bonus: * $2,000 sign-on bonus for those with grain grading experience Schedule: * 11:15am - 7:15pm, but can vary when doing rail. * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays SUMMARY: To work in the lab setting, as well as travel to offsite locations throughout the coverage area to perform visual inspection and analysis of grain to determine a grade in accordance with Eurofins Grain Inspection SOPs and USDA grain standards on multiple classes of grain or commodities; to perform mycotoxin testing, falling number, and other testing procedures on a variety of commodities. QUALIFICATION REQUIREMENTS: To perform this job successfully, Hybrid Rail Inspector must be able to work well independently and with others, have a valid driver's license, and have proof of up-to-date auto insurance. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Overnight stays for rail are a possibility on occasion. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following; however, other duties may be assigned. * Ability to work varying schedules; notifications can be on short notice; workday can vary in the number of hours required to complete an assignment. * Inspect and grade grain samples accurately and in a timely manner. When working in the lab setting, probing trucks will also be an essential duty. * Perform tests in accordance with accepted industry practice. Test samples of grain using visual procedures and equipment; test sample for weight, moisture, foreign material, damage, etc.; including mycotoxin and falling number. * Process necessary paperwork required by the Client Company and Lab Supervisor/Eurofins Grain Inspection Manager. Complete appropriate record keeping accurately and legibly. * Responsible for accuracy in reporting results; record test results and provide information to client in the form of a Grain Inspection Certificate. Responsible for timely reporting of billing information, when applicable to the Lab Supervisor/Rail Inspection Manager in the form of a Rail Report. * Demonstrate good verbal and written communication skills. Maintain regular communication with administrative staff regarding job status, progress, problems, etc. Relay information to the Lab Supervisor/Rail Inspection Manager for proper action. * Maintain grain sampling equipment properly and ensure it is in good working order. * Represent Eurofins Grain Inspection to Client Company by acting as a liaison between facility and Eurofins Grain Inspection. Exhibit excellent interpersonal and communication skills to establish and maintain effective working relationships with subordinates, peers, management, and customers. * Must be able to follow work instructions in a safe, accurate, and timely manner. * Demonstrate proven time management skills and strong attention to detail. * Ability to work well under pressure. * Demonstrate the ability to exercise discretion and independent judgment when necessary. * Exhibit a positive team mindset. * Display the ability to adhere to internal standards, policies, and procedures of Eurofins, as well as the Client's. * Assist in training incoming Inspectors in all aspects of grain inspection and all types of grain. Assist in evaluating ability and readiness of new Inspectors to assume responsibility for testing. * Other duties as assigned. Qualifications EDUCATION and/or EXPERIENCE: * High school diploma or equivalent and 1-2 years related experience preferred; however, on-the-job training could be an option. DRIVING RECORD: * Must pass motor vehicle record review * Have two years of verifiable driving experience * Must not have unacceptable driver factors in the last three years OTHER SKILLS and ABILITIES: * Ability to work autonomously. * Excellent interpersonal and organizational skills. * Excellent communication skills. * Computer skills: Knowledge of Microsoft Office; Word, Outlook, Excel, and Teams. * Attendance and reliability will be mandatory. * Responsive problem solver and action oriented. * Responsive to clients' safety and PPE requirements. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, sit, and communicate effectively. The employee is required to use different types of equipment and maintain/transfer a mobile lab on wheels for onsite mycotoxin testing. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Noise level is usually moderate. * Allergens present * Dust present Additional Information Pay Range: $16.50/Hr.- $18.50/Hr. (Commission, shift differential and milage reimbursement options). Bonus: * $2,000 sign-on bonus for those with grain grading experience Schedule: * 11:15am - 7:15pm, but can vary when doing rail. * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Food Testing is a Disabled and Veteran Equal Employment Opportunity employer.

This position is responsible for ensuring compliance with pharmaceutical industry regulations and standards as well as Company policies and procedures. This position supports ongoing quality programs across development and commercialization of products manufactured by the Company. The Sr. Quality Associate is a leader and mentor within the quality organization. Responsibilities: Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration/marketing authorization and all other requirements by reviewing manufacturing and laboratory testing records, investigations, non-conformances and out-of-specifications and analyzing cumulatively. Provides Quality leadership a summary of findings for any batch that does not meet standard requirements for final disposition. Provide batch disposition and subsequent release to market and/or marketing authorization holder, and issuance of Certificate of Analysis/Conformance according to country specific requirements Manages internal process for batch release, working closely with Quality Control, Manufacturing and Supply Chain. Responsible for communicating batch release status externally to partners, triaging questions and organizing the provision of, and providing responses in a timely manner. Coordinate activities associated with batch release, ensuring corrections are completed and associated batch documentation and investigations and events are closed out. Compiles and documents monthly metrics, quarterly reports, and ad-hoc reports and data analysis of reports. Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA) Review, consult, and approve validations and equipment/instrument qualifications (IQ, OQ, PQ, etc.) Author, review and approve risk assessments. Act as a quality representative on internal product teams, including development of products. Oversee quality system functional processes, such as Change Control. Will be assigned duties and responsibilities within the Quality System/Unit; specific duties will depend on the assignment and experience of the individual and may include any of the following: coordination/evaluation for Change Control, reviewing Annual Product Reviews, review and approval of validation documents, Events/Deviations/Investigations, evaluating effective CAPA, Product Complaints/Adverse Events, Labeling, Supplier Quality, authoring review and/or approval of standard Quality System documentation (SOPs, Forms, reports, etc.), conducting risk assessments, providing agency and partner audit support, etc. Qualifications: BS degree preferably in chemistry, biochemistry, pharmacy or related science field Minimum 5+ years-experience in pharmaceutical or biotechnology industry required. Previous experience in providing pharmaceutical Drug Product review and release. Demonstrated knowledge of GMPs and other regulatory requirements for the manufacture, testing, and release of pharmaceutical ASQ Certification preferred. Knowledge and understanding of CFR 210, 211 regulations and ability to apply Ability to make sound, independent quality decisions. Demonstrates high levels of values and integrity. Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement and be a champion of change. Excellent verbal and written communication skills both internally and externally. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This position is responsible for ensuring compliance with pharmaceutical industry regulations and standards as well as Company policies and procedures. This position supports ongoing quality programs across development and commercialization of products manufactured by the Company. The Sr. Quality Associate is a leader and mentor within the quality organization. Responsibilities: Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration/marketing authorization and all other requirements by reviewing manufacturing and laboratory testing records, investigations, non-conformances and out-of-specifications and analyzing cumulatively. Provides Quality leadership a summary of findings for any batch that does not meet standard requirements for final disposition. Provide batch disposition and subsequent release to market and/or marketing authorization holder, and issuance of Certificate of Analysis/Conformance according to country specific requirements Manages internal process for batch release, working closely with Quality Control, Manufacturing and Supply Chain. Responsible for communicating batch release status externally to partners, triaging questions and organizing the provision of, and providing responses in a timely manner. Coordinate activities associated with batch release, ensuring corrections are completed and associated batch documentation and investigations and events are closed out. Compiles and documents monthly metrics, quarterly reports, and ad-hoc reports and data analysis of reports. Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA) Review, consult, and approve validations and equipment/instrument qualifications (IQ, OQ, PQ, etc.) Author, review and approve risk assessments. Act as a quality representative on internal product teams, including development of products. Oversee quality system functional processes, such as Change Control. Will be assigned duties and responsibilities within the Quality System/Unit; specific duties will depend on the assignment and experience of the individual and may include any of the following: coordination/evaluation for Change Control, reviewing Annual Product Reviews, review and approval of validation documents, Events/Deviations/Investigations, evaluating effective CAPA, Product Complaints/Adverse Events, Labeling, Supplier Quality, authoring review and/or approval of standard Quality System documentation (SOPs, Forms, reports, etc.), conducting risk assessments, providing agency and partner audit support, etc. Qualifications: BS degree preferably in chemistry, biochemistry, pharmacy or related science field Minimum 5+ years-experience in pharmaceutical or biotechnology industry required. Previous experience in providing pharmaceutical Drug Product review and release. Demonstrated knowledge of GMPs and other regulatory requirements for the manufacture, testing, and release of pharmaceutical ASQ Certification preferred. Knowledge and understanding of CFR 210, 211 regulations and ability to apply Ability to make sound, independent quality decisions. Demonstrates high levels of values and integrity. Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement and be a champion of change. Excellent verbal and written communication skills both internally and externally. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This position is responsible for ensuring compliance with pharmaceutical industry regulations and standards as well as Company policies and procedures. This position supports ongoing quality programs across development and commercialization of products manufactured by the Company. The Sr. Quality Associate is a leader and mentor within the quality organization. Responsibilities: * Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration/marketing authorization and all other requirements by reviewing manufacturing and laboratory testing records, investigations, non-conformances and out-of-specifications and analyzing cumulatively. * Provides Quality leadership a summary of findings for any batch that does not meet standard requirements for final disposition. * Provide batch disposition and subsequent release to market and/or marketing authorization holder, and issuance of Certificate of Analysis/Conformance according to country specific requirements * Manages internal process for batch release, working closely with Quality Control, Manufacturing and Supply Chain. * Responsible for communicating batch release status externally to partners, triaging questions and organizing the provision of, and providing responses in a timely manner. * Coordinate activities associated with batch release, ensuring corrections are completed and associated batch documentation and investigations and events are closed out. * Compiles and documents monthly metrics, quarterly reports, and ad-hoc reports and data analysis of reports. * Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA) * Review, consult, and approve validations and equipment/instrument qualifications (IQ, OQ, PQ, etc.) * Author, review and approve risk assessments. * Act as a quality representative on internal product teams, including development of products. * Oversee quality system functional processes, such as Change Control. * Will be assigned duties and responsibilities within the Quality System/Unit; specific duties will depend on the assignment and experience of the individual and may include any of the following: coordination/evaluation for Change Control, reviewing Annual Product Reviews, review and approval of validation documents, Events/Deviations/Investigations, evaluating effective CAPA, Product Complaints/Adverse Events, Labeling, Supplier Quality, authoring review and/or approval of standard Quality System documentation (SOPs, Forms, reports, etc.), conducting risk assessments, providing agency and partner audit support, etc. Qualifications: * BS degree preferably in chemistry, biochemistry, pharmacy or related science field * Minimum 5+ years-experience in pharmaceutical or biotechnology industry required. * Previous experience in providing pharmaceutical Drug Product review and release. * Demonstrated knowledge of GMPs and other regulatory requirements for the manufacture, testing, and release of pharmaceutical * ASQ Certification preferred. * Knowledge and understanding of CFR 210, 211 regulations and ability to apply * Ability to make sound, independent quality decisions. * Demonstrates high levels of values and integrity. * Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement and be a champion of change. * Excellent verbal and written communication skills both internally and externally. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

DUTIES AND RESPONSIBILITIES: Perform SOP validation audits. Hands-on end process product and documentation verification audits. Properly document all audit findings timely and accurately. Suggest new SOPs and revisions to current SOPs based on audit results. Propose process improvement ideas to the Business Model to the QA Inspector II based on audit results. Monitor the use of equipment to ensure it is safe and accurate and notify area management of need to discard equipment that does not meet specified requirements. Keep measurement equipment operating accurately by following calibration requirements and notify area management of need for repairs. Report nonconformance/deviation issues to QA Inspector II. Continually identify areas of opportunity to improve efficiency and effectiveness. Advocate for quality improvement throughout the organization. May be required to participate in external supplier audits. Requirements JOB REQUIREMENTS / QUALIFICATIONS 2-3 years' experience working in a GDP/GMP or ISO environment Maintain knowledge of quality and regulatory standards relevant to the position. Excellent verbal and written communication skills. Excellent organizational skills. Keen attention to detail. General knowledge of quarantine and warehouse operations Ability to meet deadlines and to work independently in a fast-paced environment. Team player. PHYSICAL REQUIREMENTS Ability to walk or stand 85% of the workday. DESIRED KNOWLEDGE/SKILLS GMP Requirements

Job Requisition Name QA Molding Inspector Job Requisition No VN8350 USA - Sarasota Worker Basis Full Time Worker Type Employee Applications Close Date Oct 31, 2030 Purpose As a Quality Assurance Technician, you will participate in the plant's quality assurance program and ensure that manufacturing projects and processes meet all quality control standards. * Read and comprehend instructions and follow established procedures * Select components according to specifications and required schedule * Check output to ensure the highest quality * Maintain equipment in good condition * Keep records of production quantities and time; record all information on tracking sheets and in the database * Report issues, malfunctions, or defective parts * Assist with coordinating overall quality specifications and standards for processes and finished products * Inspect molded blanks * Good understanding of quality control principles * Good verbal and written communication skills * Excellent hand-eye coordination and physical condition * Dependable and detail-oriented * Ability to establish and maintain effective working relationships with coworkers, managers, and client BVI is refocusing the future of vision. As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products) and PhysIOL (Premium IOLs), and spans more than 90 countries. We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept - taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus. Learn more at ******************

Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP's, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards/procedures. Responsibilities Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel. Approve components for in-process operations. Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations. Document all work activity in appropriate batch records, forms, and logs to ensure accuracy and compliance. Sample in-process items, and finished products. Perform required inspections and testing of in-process items and finished products. Process and distribute samples to different departments. Review records for cGMP compliance for accuracy and thoroughness. Inform management of problems, failures and deviations from established internal and regulatory standards. Apply disposition sticker to components and in-process materials. Issue QA Alerts whenever any questionable component, in-process material or product is identified at any stage of production or storage. Perform swab and Rodac Plate sampling as required. Perform transactions in JD Edwards when required. Qualifications Competencies: Education / Experience: High school diploma or equivalent. Basic computer skills required. Basic math skills required (i.e., calculating %, addition, subtraction, multiplication, division). Ability to read, write, communicate and follow instructions (verbal and written) in English is required. Judgment / Decision Making: Duties performed within a framework of departmental or functional protocol requiring a minimal degree of original thinking. Work Environment: Majority of time spent at manufacturing plants with exposure to machines with moving parts airborne products, chemicals, muscular strain and noise. Carelessness could result in minor injury. May handle or work with laminates and units containing a Class II Controlled Substance. Ability to work second and third shift, if required. Ability to work Saturday and/or Sunday, if required. Physical Demands: Regularly required to stand for more than one hour at a time; occasionally lifts and carries objects weighing up to 50 pounds. Visual acuity and manual dexterity required to proofread documents and operate computer.

Quality Technician (Production) III / IV Who we are… We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that make our company a community where we make a life, not just a living. Who you are… You love details and precision. You find standardized work in which deviation could cause an undesirable outcome to be invigorating. Analyzing processes and results to control variations and discussing when improvements would best be introduced is a desirable pastime. Words that describe you are dedicated, efficient, and someone who contributes to making the workday fly by with engaging conversation and team comradery. How you make an impact… You'll provide instrumental support within the quality team and throughout the company to ensure timely product and compliance support. Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to our partners and patients. Our science and risk-based compliant quality culture is innovative and partner oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients. What you will achieve… Drive quality and compliance, adhering to all Quality Systems documentation requirements and establishing/supporting plans to exceed Niowave's goals for Quality, including Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and financial objectives. Support internal and external audits; support validation of test methods, monitoring processes, and equipment. Support new product introduction (NPI) quality activities including prototype testing, process validation, and technology transfer ensure successful product launches. Lead and participate in product/material hold, release, disposition, and traceability assessments, and implement improvements to reduce recurring deviations that lead to rework or scrap. Lead or support teams through out of tolerance, nonconformances, complaints, and CAPA investigations. Lead or support teams through change control that support continuous improvement and other needs. Lead or support Quality Assurance (QA) with completing quality checks and approvals on production records. What you need to succeed… Associates or Bachelor degree or equivalent in science or other related field. 5+ years related experience, with a solid understanding of regulatory compliance related to operations and quality procedures. Experience in quality assurance or quality control roles within a manufacturing or industrial environment. Knowledge and experience in eQMS, Inspection, Measuring and Test Equipment (IMTE) management systems, statistical process control (SPC), and root cause analysis methodologies (Six Sigma RCA). Embraces and models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal. Understands how to integrate into a new team/organization - appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state. Understands their own communication and learning styles, can assess others' styles, and is able to find the right path to connect the two. Great to have… Certification in quality management or related field (e.g., Certified Quality Technician/Engineer, Six Sigma). Experience in a facility with radiation regulatory requirements and or quality assurance experience with pharmaceuticals or medical devices. Experience with Minitab, JMP or other analytical tools. Experience in audits (internal, NRC, FDA, etc.). Knowledge of ISO 13485, 21 CFR 820, 21 CFR 210/211, and Nuclear Regulatory Commission (NRC) regulations or similar regulatory compliance experience. Work Environment The company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts. This position will have regular working hours during M - F with an expectation of adjusting to operational commitments as needed. Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role. While performing the duties of this job, the employee is occasionally required to: use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb stairs; walk throughout all locations of the company; talk and hear; wear safety glasses, googles, gloves, lab coat and/or Tyvek suit. The employee must occasionally lift or move office products and supplies, up to 25 pounds. This position may stand and sit for prolonged periods. Please provide a cover letter specifically describing the nature of your interest & expertise.

Summary/objective The Quality Technician II plays a pivotal role in ensuring the effective, efficient, compliant, and proactive support of new product launches and the continuous quality of existing products. The Quality Technician loves details and precision. This role finds standardized work in which deviation could cause an undesirable outcome to be invigorating. Analyzing processes and results to control variations and discussing when improvements would best be introduced is a desirable pastime. Words that describe the Quality Tech are dedicated, efficient, and someone who contributes to making the workday fly by with engaging conversation and team comradery.

Summary/objective The Quality Technician III plays a pivotal role in ensuring the effective, efficient, compliant, and proactive support of new product launches and the continuous quality of existing products. The Quality Technician loves details and precision. This role finds standardized work in which deviation could cause an undesirable outcome to be invigorating. Analyzing processes and results to control variations and discussing when improvements would best be introduced is a desirable pastime. Words that describe the Quality Tech are dedicated, efficient, and someone who contributes to making the workday fly by with engaging conversation and team comradery.

Essential Functions Monitor and maintain the state of inventory, quality, equipment, maintenance, calibration and facilities and ensure they comply with QS and cGMP requirements. Drive quality and compliance, adhering to all Quality Systems documentation requirements and establishing/supporting plans to exceed Niowave's goals for Quality, including Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and financial objectives. Support internal and external audits. Support validation of test methods, monitoring processes, and equipment. Support production teams in product/material hold, release, disposition, and traceability assessments, and implement improvements to reduce recurring deviations that lead to rework or scrap. Support new product introduction (NPI) quality activities including prototype testing, process validation, and technology transfer ensure successful product launches. Collaborate with cross-functional teams to support and solve production and quality challenges. Collect, monitor, analyze and communicate data to provide insight on quality metrics set by the management team.

Summary•The Quality Control Technician primary functions are to assure sterilization operations meet the quality system requirements, product is released to sterilization and shipping after review of documentation and assisting core team with quality issues. •This position will also provide training, guidance and input on quality issues to the sterilization floor. This position will also audit compliance to the quality policy and procedures. •The incumbent will participate in continuous improvement and other plant initiatives as needed in support of business goals.Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Primary Responsibilities: Performs review of sterilization documentation Releases product to the next stage of shipping Follows up on sterilization process issues/findings with appropriate parties, support investigation and suggest corrective actions. Initiate and/or respond to correction and preventive action reports. Document quality system failures and improvement activities. Conduct routine product and process audits to assure compliance to the quality system. Perform complete inspection of product according to applicable specifications. Reports issues to the Supervisor Sterilization Assurance Responsible for internal documentation updates in SAP when applicable. Document all inspections as required Update all reports and databases as required for reporting and tracking purposes Possess knowledge of Quality System Regulations and control charting defect trends in product quality. Ensure sterilization associates are properly trained in documented inspection techniques, methods, work instructions Trend quality metrics and take action to address problems and achieve departmental objectives Attend, actively participate in, and successfully complete training sessions as needed + specified. Other duties as assigned (supporting site initiatives, internal or external audits, as part of audit team members) Additionally: Support and act as Lead point person for audit and/or change control on Laboratory. Provide information in a timely manner, with relevant system evidence (e.g., Master data export, direct screen sharing with auditors, etc.). Achieve safety, quality & manufacturing/sterilization shared goals through successful delivery of key business objectives and metrics. Safety: Participate fully to achieve the department's safety goals. Maintain a clean and safe work environment. Take responsibility for own safety. Hold self-accountable to follow all safety policies & procedures Debrief accidents & implement solutions to eliminate root cause. Hold team members to safety standards/regulations & policies. Education and Experience: High School diploma or GED + 2 years of previous quality experience May have additional certificates and/or bachelor's degree in technology, Engineering, Business, or a closely related field. Experience with Quality SAP Everest Computer Skills Excel, Word High degree of discipline and demonstrates attention to detail. Proven organizational skills and ability to plan + organize work efficiently. Good understanding of requirements, QSRs, GLPs, ISO, FDA Guidelines, as well as any other regulations Strong verbal, communication and interpersonal skills are required: capacity to listen and understand users and stakeholder's expectations Must be able to work independently, but work in team environment as need it, give and receive feedback. Demonstrates personal drive and accountability to meet deadlines per project plan. Demonstrates ability to solve problems, effectively manages risks and/or escalates as needed within established governance framework, strong sense of urgency. Ability to provide operational support and autonomously address questions / inquiries from various plant (site) associates. Maintains professional working knowledge and key skills expertise current (up to date). Travel: Travel may be required for training and/or development purposes and based on business need. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. #earlycareer Required Skills Optional Skills . Primary Work LocationUSA AZ - Tucson - Valencia RoadAdditional LocationsWork Shift

Temp Quality lead Assistant - 5 years minimum practical or technical experience in quality control or CNC machining in a manufacturing environment. - Proficient in the use of hand-held calipers and micrometers as well as other measurement devices such as height gages, optical comparator, indicators, thread gages, pin gages, etc. - Good understanding of part drawing interpretation of English to metric conversions, dimensional tolerancing, revision blocks, etc. - At least 1 year experience with Excel, Word, PowerPoint, and Outlook. - Strong attention to detail. - Strong analytical and technical skills. - Record of job stability and good attendance history. - General understanding of Geometric Dimensioning & Tolerancing (GD&T) - Familiar with statistical process control (SPC) and process capability (CpK). - Proficient with creating and editing forms in Excel and PowerPoint presentations. - Thorough understanding of thread specifications and measurements. - Performed gage calibration and recording of results. - Experience with Cause & Corrective Actions. - Involved with ISO 9001 or IATF 6949 procedures and auditing. - Performed 1st & Last piece inspections. - Some familiarity with Production Part Approval Process (PPAP). Job Description: Perform shop floor inspection of parts running on screw machines and CNC mills $ lathes. Ensure quality procedures relating to operator inspections, gage usage, non-conformances and process identification are being carried out correctly. Shop floor vs. lab time skews more and more toward lab time involvement over time. - Perform incoming inspections of finished goods and WIP in the quality lab. - Recording of inspection results and generating new inspection templates in Excel. - Assisting quality lead on 1st piece approvals and gage calibration when needed. - From time-to-time, participate in defect soring and corrective actions. - Learn and operate Keyence optical measurement equipment. - Perform 1st piece inspection approvals independently. - Perform new tooling verification records & results. - Sole responsibility for scheduling and logging gage calibration records. - Assist Quality Manager in PPAP preparation. - Assist Quality Manager in internal auditing. - Generate SCARS and internal CARS for root cause and corrective actions. - Perform SPC and Cpk studies and interpretations for process improvements. - Engage in supplier interactions for process improvements. Engage in supplier interactions for quality concerns and non-conformances.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. She/he will typically work on a rotating shift schedule. Job Description ESSENTIAL FUNCTIONS: Performs in process testing for internal customers. Performs finished goods, returned goods, and stability testing for external customers as needed. Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques. Performs specified analysis on all finished goods using approved written procedures and proper laboratory techniques as needed. Maintains accurate and precise records of all laboratory analysis using appropriate Mallinckrodt recordkeeping system. Troubleshoots and performs routine maintenance on laboratory instrumentation. Prepares all standards and reagents needed for proper execution of analytical methods and procedures. Prioritizes and plans workload to meet all internal and external customer needs for maximum efficiency and accuracy. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Assists in any non-routine analytical work needed to solve plant problems. Works on solving problems and implementing improvements in a teaming environment. Uses problem solving skills to help with failure investigations and testing problems. Aids in performing any non-routine quality control related tasks such as resampling, raw material testing, and performing analysis needed to validate methods and equipment. Participates in a certified 5S Workplace System to ensure good housekeeping and organization. Assists with training others as needed. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: Associates of Science (AS) or Bachelor of Science (BS) or equivalent life science degree preferred. Appropriate experience may be a suitable replacement for degree. Experience: 1 - 3 years laboratory experience in a pharmaceutical manufacturing operation preferred. Working knowledge of cGMP is a plus. Expected Skills/Qualifications: Other Skills/Competencies: Must be able to perform basic mathematical calculations. Familiarity with basic laboratory procedures, equipment, and computer key punching. Sound and correct technical judgments are required during routine analysis. High degree of concentration is required. Ability to differentiate colors, as demonstrated by passing a test designed to identify color blindness (such as the Ishihara test). If testing criteria are not met with uncorrected vision, the use of color correcting glasses may be used as long as testing criteria are met while using them. Functional/Technical Skills, Priority Setting, Written Communication Customer Focus, Organizing RELATIONSHIP WITH OTHERS/ SCOPE: Laboratory technicians are responsible for communicating any uncompleted work to the next shift, as well as any immediate priorities. Majority of work is performed independently without direct supervision. Non-routine results, observations, or analytical requests are brought to the attention of the appropriate management personnel. Reports to Quality Testing and Release Manager. Frequent interact with operators, engineers, and Quality management for reporting routine analytical results. Communication may be though radio, telephone, email, or in person. Incorrect or inaccurate analyses can result in possible shipment of reject drug items to Mallinckrodt customers. Customer-requested specifications and Mallinckrodt methods of analysis are considered confidential for marketing purposes. Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks. Laboratory employees must be able to work effectively under these conditions. Completes all required Compliance trainings in a timely manner. WORKING CONDITIONS: Most work is performed in a well-equipped analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments. Boxes of solvents, compressed gas cylinders, old records, and reserve samples are stored in areas outside the laboratory and may require lifting and transporting to the laboratory area. Exposure to fugitive emissions of chemicals typical for chemical operations. Normal dexterity is required for routine handling of laboratory glassware and instruments. Colors must be well-visualized and slight differences in volumes of liquids in appropriate glassware distinguished. Must be able to wear the required personal protective equipment (PPE), such as hard-hat, steel-toe shoes, safety glasses, and other equipment as deemed necessary by EH&S, leadership team, corporate, or safety guidelines for the position. Must be able to work a rotating12 hour shift schedule of (7pm-7am / 7am-7pm) in addition to occasional overtime as needed. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.