Quality Control Analyst jobs at Johnson & Johnson

This position is primarily responsible for the laboratory testing of raw materials and packaging materials or in-process, release and stability samples for commercial drug products. Responsibilities: Perform accurate and timely analysis of raw materials and packaging materials or in-process, release and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements. Testing performed to include basic lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, wet chemistry techniques such as titrations. Document all laboratory testing and maintain accurate and legible notebooks and records. Peer review of data, reports and notebooks. Other projects and duties as assigned. Experience/Education Requirements: BS Degree in Chemistry or related field AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical experience in a cGMP-regulated environment BS Degree in non-science field and a minimum of 4 years of pharmaceutical experience in a cGMP-regulated environment Knowledge of cGMP, USP/NF, and FDA guidelines and regulations Experience in analytical methods and lab instrumentation (e.g. pH, ovens, titrations) Excellent oral and written communication skills Strong organization and time management skills Demonstrated ability to work as part of a cross-functional team Working knowledge of Microsoft Word and Excel Experience with software associated with a Laboratory Information Management System (LIMS) Work mainly performed in lab Stand for extended periods of time in a laboratory setting Wear Personal Protective Equipment (PPE) as needed Work with hazardous chemicals as needed to complete laboratory testing

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. This position will have the primary responsibility for daily formulation activities to ensure schedule activities are completed, formulation materials and equipment are maintained, as well as the responsibility for performing corrective and preventative actions. As a secondary function, provide troubleshooting expertise for manufacturing of products both internally and externally of the company. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. + Has ownership for the daily formulation activities to ensure scheduled all scheduled tasks/events are completed + Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or finical loss + Initiate the production of batch documentation used for engineering and cGMP production. + Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation changes + Complete executed Batch Records accurately and completely prior to submission to supervision for review + Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements + Author process deviations when these occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions + Cross train to increase technical skills across the department + Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements. + As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed. + Work with enabling groups to improve/implement processes. + Other duties as assigned. + Strong interpersonal skills + Strong working knowledge of MS Office suite is preferable + Attention to detail and positive attitude are key attributes + Able to follow rules and regulations perfectly + Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc. **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **Required:** + High School education or AS degree or BS degree in Chemical Engineering/ Bio Chemistry or other industry related discipline is preferred + Experience and knowledge of formulation/compounding tools and equipment + Minimum 1-2 year's work experience in a GMP environment preferably in fill finish pharmaceutical operations + Demonstrated ability to prioritize multiple projects and activities Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. \#LI-KC1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . **Astellas Institute for Regenerative Medicine (AIRM)** is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a **QC Scientist I Raw Materials** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.** **Purpose:** The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. **Essential Job Responsibilities:** + Develop/author/revise technical reports and laboratory procedures (SOPs, methods) + Execute and troubleshoot raw material testing in support of production activities + Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures + Design and perform testing in support of method transfer/validation/qualification/verification + Review/authorize data and perform analysis and interpretation of test results and trends + Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations + Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration + Support and mentor junior team members + Collaborate with other network sites to share best practices + Other duties as required **Quantitative Dimensions:** The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. **Organizational Context:** The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization **Qualifications** **Required:** + B.S. degree in chemistry, biological sciences or related field with 6+ years or M.S. degree with 4+ years of relevant experience in a GMP Quality Control role + Prior laboratory hands-on experience with a variety of techniques such as FTIR, Raman, Near-IR, HPLC analysis and other compendial assays + Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing + Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements) + Ensures inspection, testing and release timelines are met. + Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven experience analyzing experimental data + Experience using LIMS as an end user; Excellent technical writing and verbal communication skills + Must be capable of observing and adhering to lab safety standards and procedures + Successfully performs work independently with minimal instructions + Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements + Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion + Highly self-motivated and goal oriented + Will support and demonstrate quality standards to ensure data of highest quality and works closely with team and other functional key stakeholders on the Astellas Operations team to execute work and will be expected to perform other duties and/or special projects as assigned **Preferred:** + Experience in a Biotech/Pharmaceutical company with a high growth, fast-paced environment + Experience in qualification of analytical equipment, including those with computerized systems + Experience in method validation/qualification/verification/transfer **Working Conditions:** + This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. + This is an on-site role working in a cGMP regulated manufacturing facility. **Salary Range** : $91,000-$143,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits** : + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program _All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability._ \#LI-TR1 Category Massachusetts TC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: Develop/author/revise technical reports and laboratory procedures (SOPs, methods) Execute and troubleshoot raw material testing in support of production activities Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures Design and perform testing in support of method transfer/validation/qualification/verification Review/authorize data and perform analysis and interpretation of test results and trends Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration Support and mentor junior team members Collaborate with other network sites to share best practices Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a QC Scientist I Raw Materials opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Essential Job Responsibilities: * Develop/author/revise technical reports and laboratory procedures (SOPs, methods) * Execute and troubleshoot raw material testing in support of production activities * Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures * Design and perform testing in support of method transfer/validation/qualification/verification * Review/authorize data and perform analysis and interpretation of test results and trends * Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations * Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration * Support and mentor junior team members * Collaborate with other network sites to share best practices * Other duties as required Quantitative Dimensions: The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. Organizational Context: The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Research Chemist (E&L) We are seeking an experienced Research Chemist (E&L) with a minimum of 3-5 years of pharmaceutical industry experience. Responsibilities: Maintain, operate, and troubleshoot LC-MS and GC-MS, GC-FID, and ICP-MS Systems. Perform extraction, analysis, and characterization of extractables and leachables from polymeric materials associated with container closure systems of pharmaceutical drug products as per USP, PQRI, ICH and other regulatory guidelines. Develop and optimize sample preparation techniques for analysis on GC-MS, LC-MS, and ICP-MS systems. Develop and validate LC-MS, GC-MS, and ICP-MS methods for finished product and raw material characterization as well as extractable/leachable testing. Unknown impurity identifications using GC-MS, LC-MS, and LC-MS/MS or other suitable techniques. Interpret complex spectral data and fragmentation patterns. Routine stability testing of API, finished product samples for assay and impurities using various instrumental techniques as suited, and prepare stability data summaries. Generate study designs, write protocols, methods, Datasheets and reports. Provide support in the critical review of analytical data, reports and protocols. Write Instrument-related SOPs and provide training on the instrument and related software. Train new recruits in the lab and support the team as needed. Participate in internal meetings and conferences. Provide support during technical transfer between R&D and QC. Whenever needed, attend SOP, Safety, and scientific trainings to remain current with cGMP regulations, safety standards, and development technologies. Preparation and review of analytical methods, method validation, and related study reports for ANDA/ NDA submissions and support, document preparation for ANDA/ NDA submissions. Any other activities as directed by the supervisor. Qualifications: Education/Experience: Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. Knowledge, Skills, and Abilities: Familiarity with the characterization and isolation of impurities. Strong foundation in organic chemistry and structural elucidation, with expertise in small molecule pharmaceutical drug development and peptides, including computational techniques. Proficiency in using standard laboratory equipment, including pipettes, graduated cylinders, and balances. Skilled in laboratory techniques for measuring, weighing, and handling samples. Hands-on experience with HPLC (highly preferred). Knowledge of chemical handling procedures, including safety precautions and documentation such as Safety Data Sheets (SDS). Competency in Microsoft Office applications. Experience or familiarity with current Good Manufacturing Practices (cGMP) is preferred. Requirements: Must live or be willing to move to the Sacramento Metropolitan Region (Approximately 40 miles' radius) Benefits: Pay range $70,000 - $85,000 per Year Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401 (k) savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment o retaliation based on any of these factors.

Boehringer Ingelheim Animal Health is currently seeking an innovative, tech savvy Co-Op to join our Commercial Quality team located at our Duluth, GA US headquarters. As a Co-Op, you will learn basic quality principles while performing critical process evaluations. The mission of this internship will be to streamline a critical quality process which contributes to the continuity of the US Animal Health Commercial Supply Chain. As a Co-Op at Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities Assist Subject Matter Experts in core quality tasks associated with release of batches to the US market, deviation management, and complaint management Evaluate a core quality process and use BI digital tools (i.e. Tableau, Power BI, Dashboards, Excel, DocuSign) to streamline the process Develop and execute quality culture initiatives to spread Quality Culture across the US AH Commercial business Requirements Must be a current undergraduate, graduate or advanced degree student in good academic standing. Student must be enrolled at an accredited college or university for the duration of the Co-Op. Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred. Major or minor in related field of the Co-Op. Undergraduate students must have completed at least 12 credit hours at current college or university. Graduate and advanced degree students must have completed at least 9 credit hours at current college or university. Desired Skills, Experience and Abilities Advanced skills in Excel, Dashboards, and/or Power BI Strong organization skills Proficient in MS PowerPoint Excellent written and verbal communication Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

The Quality Control Operator ensures the products meet their respective specifications and quality standards by performing physicochemical analyzes, measurement testing, and monitoring steps of the production process. Responsibilities: Product sampling and quality monitoring. Physicochemical analysis of food products. Measurement testing, such as finished product weight and oxygen level. Critical Control Point (CCP) monitoring. Maintenance of quality control records. Compliance with the QA laboratory procedures. Compliance with Good Manufacturing Practices (GMP), and Quality & Food Safety guidelines. Support the 5S program in the manufacturing facility, keeping working areas, utensils, and equipment clean and organized. Compliance with company safety rules and procedures, providing support to eliminate any unsafe conditions. Support to all quality shifts, as needed. Any other duties assigned by the management. Education/Experience/Knowledge: High School Graduate or equivalent work experience. Basic computer skills including Microsoft Office applications and Windows environment. Ability to do math computation and calculation. Ability to maintain a positive work atmosphere by behaving and communicating professionally and effectively with others as well as being able to receive feedback from others. Time management and teamwork skills. Verbal and written communication skills. High level of integrity. Able to work on the weekends, as needed. Bilingual (English and Spanish), preferred. Why work for Advance Services, Inc. 1. Advance Services is for and about people; we are your employment specialists. 2. Enjoy our easy application process. 3. You NEVER pay a fee! 4. Weekly pay. 5. Fun Safety and attendance incentives. 6. Health Benefits to keep you and your family healthy. 7. PTO so you have time for yourself. 8. Great Referral Incentives. 9. Advance Services partners with the top companies in the area! Apply for this job by clicking the apply button. You will be directed to our website. Please select a branch near you or call/text our office at *************. Stop in and see our experienced, friendly staff at 1908 Central Dr, Suite A, Bedford, TX 76021. Advance Services is an equal-opportunity employer.#456

Job Title: Scientist, Production Reports To: Manager, Operations Work Type: Onsite FLSA Status: Non-exempt Individuals serving in this position will be working in manufacturing, product development, and Quality testing at the Diagnostics business units. Employees will be trained in a variety of lab techniques specific to the department assigned as well as document generation and completion. The incumbent must be a dynamic individual who can multi-task and perform various activities associated with manufacturing operations while adhering to all safety policies and high quality Standard Operating Procedures. This position requires hands on lab work and will report to the Lab or Production Manager. Key Responsibilities: · Execution of quality system procedures · Proper execution of SOPs, safety guidelines, and work instructions for manufacturing procedures assigned by supervisor · Ability to work individually as well as part of a team towards completion of specific projects · Use of manufacturing related equipment as required by work instructions and SOPs · Data analysis · Demonstration of sound problem-solving skills and troubleshooting abilities · Communicate exceptions to established/agreed upon schedules to all affected parties internal and external. · Adherence to quality systems with special regard to FDA, ISO 13485 and GMP / OSHA compliance · QC testing of components and finished products including organization of inventory, weighing actual hands-on inventory and updating systems. · Inventory management of materials and supplies · Focus on continual process improvement · Cleaning and maintenance of equipment · Guided experimental design and product testing assigned by supervisor · Preparation of reagents, media, and buffers · Performs other duties as assigned Department Specific Potential Duties: Chemistry · Assist and manufacture inorganic or organic products using knowledge of chemistry principles. · Experience with general chemistry glassware, lab supplies and concentrated acid handling · Experience with hot block digestion, auto pipettes, and sample preparation preferred. · Basic mathematics and familiarity with general chemistry calculations Experience: · 4-year B.S. degree required in biology, microbiology, chemistry, or other life sciences program · Relevant experience in laboratory skills/cGMP preferred. Including but not limited to pipetting, preparing reagents, centrifugation, recording observations, etc. Qualifications: · Ability to analyze and interpret data and results · Proficiency in Microsoft Office · Strong analytical, problem solving, process improvement skills · Attention to detail · Ability to multitask and adapt to changing priorities · Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints · Excellent communication skills, both written and verbal, to communicate to all levels of the organization clearly and concisely · Strong work ethic and an ability to excel within a rapidly changing and growing organization · Willingness to cross train and support other teams as needed for our medium sized business. Physical Requirements/Working Conditions: · Potential Hazards: solvents, acids, bases, infectious organisms, carcinogens, combustibles, fast paced environment, repetitive motion, · Recommended PPE: Closed toe shoes, lab coats, gloves, safety goggles, Tyvek suits in level three biohazard laboratories Compensation & Benefits: Salary Range: $20/hr-$36/hr, depending on location, experience, and qualifications. Benefits coverage begins day 1, including the following: Medical, Dental, Vision Insurance Disability Insurance Life Insurance 401(k) company match Paid Time Off (15 days annually) Paid Holiday time (10 company-designated days) Tuition Assistance Additional benefits available with company package This position has not been approved for Relocation Assistance. The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

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 Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts. Job Description The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists. * Support microbial testing for commercial and pre-commercial products * Support method development, validation, and transfer activities * Perform complex microbial analyses using lab equipment * Investigate complex product issues and support product development * Manage method lifecycle activities * Write and review SOPs, test methods, and validation documents * Serve as a subject matter expert (SME) in microbial testing * Mentor Scientists and Microbiologists Key Responsibilities * Perform routine microbiological testing on raw materials, in-process samples, and finished products * Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests * Analyze environmental monitoring samples from cleanrooms and production areas * Support Validation of microbial methods for product and raw material testing * Prepare protocols, reports, and test methods * Conduct testing to support development and stability studies * Present and review data with project teams * Review lab documentation and supplier technical documents * Use lab software and detect abnormalities during testing * Provide general lab support and maintain equipment * Troubleshoot instruments and perform follow-up analyses * Report and investigate out-of-specification results * Write and review SOPs and investigation reports that support root cause analysis * Recommend corrective and preventive actions (CAPA) * Support training of microbiologists and improve training process records * Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) * Ensure compliance with FDA and other regulatory standards * Follow safety procedures and handle hazardous materials properly * Uses laboratory software for analyses * Is alert to and detects abnormalities during performances of tests and reviews 65% Lab Equipment * Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping * Troubleshoots instrumentation and performs subsequent analyses 20% Investigations * Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action * Participates in root cause identification of complex laboratory investigations * Writes, edits, and reviews SOPs and laboratory investigations 10% Training * Trains microbiologists * Continuously updates knowledge with respect to the latest technologies related to Microbiology * Maintains assigned training records current and in-compliance * Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures 5% Compliance * Identifies need for SOPs and writes or revises, as appropriate * Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations * Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs * Takes active role in auditing laboratory logbooks/documentation to ensure compliance * Follows internal processes related to controlled substances continuous Safety * Follows EH&S procedures to ensure a safe work environment * Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job * Bachelor of Science Degree in Microbiology or related field with 6 years' relevant microbiological laboratory experience OR * Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR * PhD in above disciplines with some relevant laboratory experience preferred Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. * Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc. * Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc. * Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS * Has demonstrated competence in conducting microbial testing * Strong knowledge of aseptic technique and contamination control * Competency in Microsoft Office Suite Skills & Abilities Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. * Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information * Ability to display and analyze data in a logical manner * Strong verbal and written communication skills as well as good computer skills * Strong attention to details and accurate record keeping * Establish and maintain cooperative working relationships with others * Solid organizational skills * Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities * Ability to take initiative, set priorities and follow through on assignments 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. * 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 Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. EEO Statement: We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Essential Functions: * Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations. * Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. * Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator. * Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. * Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies. * Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Additional Responsibilities: * Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. * Ensure that expired chemicals and reference standards are removed from laboratory area. * Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. * Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.

The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Essential Functions: Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations. Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator. Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies. Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Additional Responsibilities: Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. Ensure that expired chemicals and reference standards are removed from laboratory area. Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels. Education: Bachelors Degree (BA/BS) Chemistry or related science discipline - Required Master Degree (MS/MA) Chemistry or related science discipline - Preferred Experience: With a Bachelors Degree (BA/BS) -5 years or more of testing of chemicals/pharmaceutical products With a Masters Degree (BA/BS) -3 years or more of testing of chemicals/pharmaceutical products Skills: Must be precise and consistent in day to day analysis, easily trainable and ready to learn. - Advanced Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Advanced Must be able to execute compendial procedures involving complexity with no or minimal supervision. - Intermediate Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Intermediate Must be able to assume a role of a leader in team environment as and when required. - Intermediate Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Intermediate Must be willing to work extended hours, including weekends, as and when required. - Intermediate Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Advanced Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Advanced Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. - Advanced Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate Specialized Knowledge: Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques). Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis. Must understand and apply cGMP requirements applicable to quality control laboratory. Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner. Must be able to identify trends in analytical data. The base salary for this position ranges from $90,000 to $95,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Formulation Technician III mentors others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety Guidelines of PCI. With general supervision, the technician performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, and aseptic compounding activities for biopharma and medical device products. The incumbent must possess the ability to address non routine matters. Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction to ensure proper behaviors. Escalates matters requiring resolution by management. Works with Master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action Trains and mentors both peers and less experienced staff in the performance of proper formulation techniques Has ownership for the daily formulation activities to ensure all scheduled tasks/events are completed Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention of errors that could lead to product and or finical loss Troubleshoots and resolve problems with equipment or processes in the course of performing job duties Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation Prepares equipment and components for sterilization and Lyophilization Operates processing equipment including autoclaves, depyrogenation ovens, vial washers, homogenizers, and others Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs Collaborates with Supervisor and MTS during drafting of new manufacturing batch records and protocols. Completes Batch Records accurately and completely prior to submission to supervision for review Complies with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements Initiate and support revisions to SOPs and FORMs as needed Participates in investigations, and contribute to identifying corrective and preventative actions Cross trains to increase technical skills across the department Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients Work with enabling groups to improve/implement processes Other duties as assigned Special 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. Able to stand for long periods of time, the majority of the work shift Able to lift 30lbs repeatedly Able to wear PPE (mask, gloves, respiratory) 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. Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc. TRAVEL - < 10% Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. High School education, AS degree or BS degree in related field of study is preferred Experience and knowledge of formulation/compounding tools and equipment Minimum 4 years formulation/compounding work experience in a GMP environment, preferably in fill finish pharmaceutical operations Demonstrated ability to prioritize multiple projects and activities Strong interpersonal skills Strong working knowledge of MS Office suite is preferable Strong communication skills Attention to detail and positive attitude are key attributes Able to follow rules and regulations perfectly Resilient as well as flexible Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Job Description This position functions primarily in a classified ISO-8 environment and requires the individual to wear appropriate PPE. This position will perform dispensing and formulation operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required. Schedule: Tuesday to Friday 3 PM Until 1:30 AM (or until work is completed) Pay: $25/hour SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies. Authorized to immediately stop any task that is determined to be an imminent hazard. Always promote and demonstrate safe work practices and adhere to PPE requirements. Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-8 dispensing and formulation operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for formulation operations. Complete and document required training to gain proficiency for all assigned job tasks. Accurately and contemporaneously document all actions performed per GDP standards. Assist with classified and non-classified area cleaning and maintenance as required. Perform visual inspection, labeling, and additional support tasks as required. Make recommendations for process improvements. Possess the ability to master multiple processes across different areas. Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding. Maintain a quality focused, “Right First Time”, attitude. Arrive for work on-time, prepared to work in the classified environment for the majority of each shift. Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions. Ensure patient safety by understanding you and your team's impact on product quality. Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. High School Diploma or equivalent. Must pass a drug test. Must speak, write, and read English. Must be a team player. Must have excellent attention to detail. Prior Sterile Compounding and Pharmaceutical Industry experience. Prior experience operating manufacturing equipment/machinery. Knowledge of FDA guidelines, cGMP, and GDP. Willingness to participate in training and gain other certifications as needed. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands. Excellent written and verbal communication skills. Desire to expand knowledge and grow with the company. Leadership ability.

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 Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts. Job Description The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists. Support microbial testing for commercial and pre-commercial products Support method development, validation, and transfer activities Perform complex microbial analyses using lab equipment Investigate complex product issues and support product development Manage method lifecycle activities Write and review SOPs, test methods, and validation documents Serve as a subject matter expert (SME) in microbial testing Mentor Scientists and Microbiologists Key Responsibilities Perform routine microbiological testing on raw materials, in-process samples, and finished products Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests Analyze environmental monitoring samples from cleanrooms and production areas Support Validation of microbial methods for product and raw material testing Prepare protocols, reports, and test methods Conduct testing to support development and stability studies Present and review data with project teams Review lab documentation and supplier technical documents Use lab software and detect abnormalities during testing Provide general lab support and maintain equipment Troubleshoot instruments and perform follow-up analyses Report and investigate out-of-specification results Write and review SOPs and investigation reports that support root cause analysis Recommend corrective and preventive actions (CAPA) Support training of microbiologists and improve training process records Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) Ensure compliance with FDA and other regulatory standards Follow safety procedures and handle hazardous materials properly Uses laboratory software for analyses Is alert to and detects abnormalities during performances of tests and reviews 65% Lab Equipment Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping Troubleshoots instrumentation and performs subsequent analyses 20% Investigations Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action Participates in root cause identification of complex laboratory investigations Writes, edits, and reviews SOPs and laboratory investigations 10% Training Trains microbiologists Continuously updates knowledge with respect to the latest technologies related to Microbiology Maintains assigned training records current and in-compliance Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures 5% Compliance Identifies need for SOPs and writes or revises, as appropriate Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs Takes active role in auditing laboratory logbooks/documentation to ensure compliance Follows internal processes related to controlled substances continuous Safety Follows EH&S procedures to ensure a safe work environment Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job Bachelor of Science Degree in Microbiology or related field with 6 years' relevant microbiological laboratory experience OR Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR PhD in above disciplines with some relevant laboratory experience preferred Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc. Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc. Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS Has demonstrated competence in conducting microbial testing Strong knowledge of aseptic technique and contamination control Competency in Microsoft Office Suite Skills & Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information Ability to display and analyze data in a logical manner Strong verbal and written communication skills as well as good computer skills Strong attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities Ability to take initiative, set priorities and follow through on assignments 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. 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 Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. EEO Statement: We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

**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 Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts. **Job Description** The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists. + Support microbial testing for commercial and pre-commercial products + Support method development, validation, and transfer activities + Perform complex microbial analyses using lab equipment + Investigate complex product issues and support product development + Manage method lifecycle activities + Write and review SOPs, test methods, and validation documents + Serve as a subject matter expert (SME) in microbial testing + Mentor Scientists and Microbiologists **Key Responsibilities** + Perform routine microbiological testing on raw materials, in-process samples, and finished products + Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests + Analyze environmental monitoring samples from cleanrooms and production areas + Support Validation of microbial methods for product and raw material testing + Prepare protocols, reports, and test methods + Conduct testing to support development and stability studies + Present and review data with project teams + Review lab documentation and supplier technical documents + Use lab software and detect abnormalities during testing + Provide general lab support and maintain equipment + Troubleshoot instruments and perform follow-up analyses + Report and investigate out-of-specification results + Write and review SOPs and investigation reports that support root cause analysis + Recommend corrective and preventive actions (CAPA) + Support training of microbiologists and improve training process records + Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) + Ensure compliance with FDA and other regulatory standards + Follow safety procedures and handle hazardous materials properly + Uses laboratory software for analyses + Is alert to and detects abnormalities during performances of tests and reviews 65% Lab Equipment + Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping + Troubleshoots instrumentation and performs subsequent analyses 20% Investigations + Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action + Participates in root cause identification of complex laboratory investigations + Writes, edits, and reviews SOPs and laboratory investigations 10% Training + Trains microbiologists + Continuously updates knowledge with respect to the latest technologies related to Microbiology + Maintains assigned training records current and in-compliance + Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures 5% Compliance + Identifies need for SOPs and writes or revises, as appropriate + Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations + Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs + Takes active role in auditing laboratory logbooks/documentation to ensure compliance + Follows internal processes related to controlled substances continuous Safety + Follows EH&S procedures to ensure a safe work environment + Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience _Minimal acceptable level of education, work experience and certifications required for the job_ + Bachelor of Science Degree in Microbiology or related field with 6 years' relevant microbiological laboratory experience OR + Master's Degree in above disciplines with 4 years' relevant analytical lab experience OR + PhD in above disciplines with some relevant laboratory experience preferred Knowledge _Proficiency in a body of information required for the job_ _e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc. + Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc. + Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS + Has demonstrated competence in conducting microbial testing + Strong knowledge of aseptic technique and contamination control + Competency in Microsoft Office Suite Skills & Abilities _Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing_ _etc._ + Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information + Ability to display and analyze data in a logical manner + Strong verbal and written communication skills as well as good computer skills + Strong attention to details and accurate record keeping + Establish and maintain cooperative working relationships with others + Solid organizational skills + Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities + Ability to take initiative, set priorities and follow through on assignments 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._ + 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 **_Disclaimer:_** _The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required._ **EEO Statement:** We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit. 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.

Job Description This position functions primarily in a classified ISO-8 environment and requires the individual to wear appropriate PPE. This position will perform dispensing and formulation operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required. Schedule: Monday to Thursday 5 AM until 3:30 PM (or until work is completed) Pay: $23/hour SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies. Authorized to immediately stop any task that is determined to be an imminent hazard. Always promote and demonstrate safe work practices and adhere to PPE requirements. Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds. Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-8 dispensing and formulation operations consistent with established protocols, procedures, and regulatory/cGMP requirements. Learn to utilize all relevant equipment/technology for formulation operations. Complete and document required training to gain proficiency for all assigned job tasks. Accurately and contemporaneously document all actions performed per GDP standards. Assist with classified and non-classified area cleaning and maintenance as required. Perform visual inspection, labeling, and additional support tasks as required. Make recommendations for process improvements. Possess the ability to master multiple processes across different areas. Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding. Maintain a quality focused, “Right First Time”, attitude. Arrive for work on-time, prepared to work in the classified environment for the majority of each shift. Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions. Ensure patient safety by understanding you and your team's impact on product quality. Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines. Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. High School Diploma or equivalent. Must pass a drug test. Must speak, write, and read English. Must be a team player. Must have excellent attention to detail. Prior Sterile Compounding and Pharmaceutical Industry experience. Prior experience operating manufacturing equipment/machinery. Knowledge of FDA guidelines, cGMP, and GDP. Willingness to participate in training and gain other certifications as needed. Knowledge of basic arithmetic and chemistry calculations. Ability to work in a fast-paced environment with dynamic priorities and demands. Excellent written and verbal communication skills. Desire to expand knowledge and grow with the company. Leadership ability.

Role Description This Quality Scientist I position is responsible for testing of blended vaccines and antigen stocks for potency, extraneous agents, inactivation, and identity using egg based and tissue culture-based methodology. Maintain testing schedules and prioritization of testing to ensure timely completion of assays to meet the established release dates. Following GMP documentation guidelines. Completion of test records and system data entry. Basic problem-solving skills and demonstrate trouble shooting ability and writing Laboratory Investigations when necessary, utilizing Method 1 and the DMAIC process. Contribute to the team's productivity goals. Cleaning and maintaining lab equipment, instrumentation, and facility. The colleague should have the ability to follow detailed instructions. Position Responsibilities: * Testing of samples from manufacturing to ensure Quality and compliance according to all applicable assays utilizing good aseptic practices. * Maintaining testing schedules and reagent supply * Completion of documentation following cGMP guidelines * Cleaning and maintaining lab equipment, instrumentation, and facility. * Following all Zoetis Quality Standards, Policies and Procedures * Providing minimum input for laboratory investigations (LIR), minimal project support * Understanding of the QC software packages used during routine work. * Pipette work and analytical techniques. * Preparation of media and reagents * Equipment monitoring. * Properly utilize computer software used during routine work. * Understand and execute excellent aseptic technique. * Perform egg drilling, candling, and other egg manipulations. * Perform culture of primary and continuous cell lines * Participate in Media Fill inspections. * Participate in all required training activities. * Work in a safe manner and follow safety policies and procedures. * Demonstrate basic problem-solving skills and troubleshooting ability. * Perform basic laboratory math accurately (dilutions, titrations, cell counts, etc.) * Record procedures and results using proper cGMP documentation. * Effectively work in a team environment and communicate with multiple departments. Education and Experience: 2 to 4 Year Degree (science background preferred) and/or 0-3 years of relevant experience. * Knowledge of cGMP/GLP requirements. * Experience with Microsoft Office software (Word, Excel, and PowerPoint) * Strong attention to detail, ability to work well independently and as a part of a team, and to work effectively with people at all levels within the organization. * Ability to follow detailed instructions with coaching. * Willingness to positively embrace change and flexibility in adjusting to changing priorities. * Gain proficiency in 50% of the testing in a specified area. Preferred: * Experience with cell culture and/or egg-based propagation of viruses. * Experience using aseptic technique. * Work experience in a cGMP/GLP environment. Physical Requirements: * Must be able to walk, sit, or stand for long periods of time. * Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently. * Must be able to work scheduled 40 hours with the ability to work overtime as needed. * Frequent lifting and carrying of 5 to 25 lbs. * Regular reaching, bending, stooping, and twisting. * Repetitive motion and substantial movement of the wrists, hands, and/or fingers. * Ability to grasp and manipulate objects like pipettors, flasks, and bottles. * Flexibility to cover rotating weekend duties. Full time Regular Colleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Data Review Scientist will be responsible for reviewing laboratory data and supporting documentation to ensure that they are compliant with SOPs, and compendial and CGMP requirements. This individual must have knowledge of instrument theory in order to thoroughly vet and review data and draw conclusions based on collected data. Responsibilities Reviews raw technical data provided by technicians, chemists and laboratory supervision to ensure accuracy, completeness and correct scientific conclusions have been drawn. Data may include Analytical Records, notebooks, logbooks, spectra, chromatograms, other instrument output and any other information supporting Analytical Records. Identifies data inaccuracies, incomplete inferences and works directly with laboratory staff to provide guidance and direction on the correction of laboratory data packages. Verifies and ensures that conclusions drawn on laboratory data are sound and accurate and representative of materials under examination. Maintains and manages cGMP and controlled substance systems in all QC/PSG labs at defined levels of compliance in accordance with site approved procedures and protocols. Maintains open communication within and across departments to ensure timely delivery and approval of laboratory documents. Works alternative schedules to support output and data review of laboratories based on business need. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned. Qualifications/Skills Strong chemistry knowledge with proven ability to handle various project loads is beneficial. Education, Experience & Licensing Requirements Bachelor's degree in chemistry with three years' experience in a pharmaceutical and cGMP environment highly preferred. Experience in a laboratory environment highly preferred. Knowledge of analytical instrumentation (GC, HPLC, FTIR, UV-VIS, etc. ) required. Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program. ' Relocation assistance will be offered for this position. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1 All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Bachelor's degree in chemistry with three years' experience in a pharmaceutical and cGMP environment highly preferred. Experience in a laboratory environment highly preferred. Knowledge of analytical instrumentation (GC, HPLC, FTIR, UV-VIS, etc. ) required. Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program. ' Relocation assistance will be offered for this position. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1Reviews raw technical data provided by technicians, chemists and laboratory supervision to ensure accuracy, completeness and correct scientific conclusions have been drawn. Data may include Analytical Records, notebooks, logbooks, spectra, chromatograms, other instrument output and any other information supporting Analytical Records. Identifies data inaccuracies, incomplete inferences and works directly with laboratory staff to provide guidance and direction on the correction of laboratory data packages. Verifies and ensures that conclusions drawn on laboratory data are sound and accurate and representative of materials under examination. Maintains and manages cGMP and controlled substance systems in all QC/PSG labs at defined levels of compliance in accordance with site approved procedures and protocols. Maintains open communication within and across departments to ensure timely delivery and approval of laboratory documents. Works alternative schedules to support output and data review of laboratories based on business need. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.