Quality Control Associate jobs at Biogen - 264 jobs

It's not what we make. It's what we make possible and the possibilities at Lifecore are endless! This full-time 2nd shift position offers incredible benefits, a four-day work week, competitive pay, and a company culture focused on development and growth which includes promotion opportunities. The QC Microbiologist II will ensure accurate, reproducible, and timely QC testing in support of manufacturing. In addition, this position will support development, validation, and stability studies on and as needed basis; participate in methods improvement within the laboratory. They will have the opportunity to: * Identify and report OOT and OOS results as testing is in process. * Assist in troubleshooting equipment and method failures. * Perform testing on in-process products, final product, and raw materials for routine testing, validation testing, and stability testing. * Communicate results through appropriate documentation and batch records, statistical analysis, and trending. * Acquire and maintain cleanroom and going qualification. This entails maintaining proper hygiene and meeting physical challenges (balance, flexibility etc) that are involved in the gowning process. This position could be a great fit for you if you have a high attention detail and enjoy working in a fast-paced laboratory along with the following: * BS in Microbiology or related life science * 2-5 years of experience in lab applications * GMP laboratory experience strongly preferred * Hands-on experience with one of the following: Sterility, Bioburden, endotoxin testing or environmental monitoring * Established ability to identify and resolve technical problems * Proven ability to work independently as well as function effectively as a team member * Proven ability to maintain a high attention to detail Schedule: Monday - Thursday, 12:00pm - 10:30pm Starting Salary: $62,000 - $70,000 annual + $100 per pay period shift premium Lifecore offers a highly competitive total rewards package, including: * Opportunities to learn and grow with a well-respected company * Competitive compensation with annual reviews and a company-wide incentive bonus * Benefits that start the first of the month after you join Lifecore as a full-time employee: * 3 medical insurance plans to fit your needs and budget including an HSA Plan with a generous company contribution. * Low cost dental and vision insurance * Short term disability, long term disability and life insurance all 100% company paid * 3 weeks PTO in the first year (increases to 4 weeks after just 2 years!) * 9 paid company holidays plus 1-2 personal holidays * 4 weeks of paid family leave after 1 year of employment * Tuition reimbursement * 401k plan with company matching contribution Meet Lifecore Biomedical, LLC: Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories.

It's not what we make. It's what we make possible and the possibilities at Lifecore are endless! This full-time 2 nd shift position offers incredible benefits, a four-day work week, competitive pay, and a company culture focused on development and growth which includes promotion opportunities. The QC Microbiologist II will ensure accurate, reproducible, and timely QC testing in support of manufacturing. In addition, this position will support development, validation, and stability studies on and as needed basis; participate in methods improvement within the laboratory. They will have the opportunity to: Identify and report OOT and OOS results as testing is in process. Assist in troubleshooting equipment and method failures. Perform testing on in-process products, final product, and raw materials for routine testing, validation testing, and stability testing. Communicate results through appropriate documentation and batch records, statistical analysis, and trending. Acquire and maintain cleanroom and going qualification. This entails maintaining proper hygiene and meeting physical challenges (balance, flexibility etc) that are involved in the gowning process. This position could be a great fit for you if you have a high attention detail and enjoy working in a fast-paced laboratory along with the following: BS in Microbiology or related life science 2-5 years of experience in lab applications GMP laboratory experience strongly preferred Hands-on experience with one of the following: Sterility, Bioburden, endotoxin testing or environmental monitoring Established ability to identify and resolve technical problems Proven ability to work independently as well as function effectively as a team member Proven ability to maintain a high attention to detail Schedule: Monday - Thursday, 12:00pm - 10:30pm Starting Salary: $62,000 - $70,000 annual + $100 per pay period shift premium Lifecore offers a highly competitive total rewards package, including: Opportunities to learn and grow with a well-respected company Competitive compensation with annual reviews and a company-wide incentive bonus Benefits that start the first of the month after you join Lifecore as a full-time employee: 3 medical insurance plans to fit your needs and budget including an HSA Plan with a generous company contribution. Low cost dental and vision insurance Short term disability, long term disability and life insurance all 100% company paid 3 weeks PTO in the first year (increases to 4 weeks after just 2 years!) 9 paid company holidays plus 1-2 personal holidays 4 weeks of paid family leave after 1 year of employment Tuition reimbursement 401k plan with company matching contribution Meet Lifecore Biomedical, LLC: Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories.

Summary of Primary Responsibilities: Responsible for all microbiological and some analytical testing of production materials under GMP conditions. Responsible for process and equipment validation (autoclave and depyrognenation oven) in cooperation with Engineering and R&D (New Product Sterility and LAL validation.) Specific Responsibilities: Perform bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samples Perform company's purified water and DI water bioburden, endotoxin and TOC testing as per USP requirements Complete all required documentation according to SOP Verify work of technicians and assist in training Review environmental condition of classified areas, maintain database for environmental results of clean room environment and summarize data for annual environmental report Provide training on environmental compliance issues Development and validation of new or improved microbiological methods Writing and/or approving validation protocols, coordinating and/or performing validation and writing and/or approving validation reports Establishing databases for microbiological and validation data Performs Internal Audits as scheduled Other duties and projects as assigned Job Complexity: Works on complex problems requiring in-depth analysis and evaluations of factors, and on assignments that are required to be performed according to defined procedures and practices. Exercises considerable judgment and initiative within broadly defined practices and policies in selecting methods and techniques. Normally receives no instruction on routine work, general instructions on new assignments. Supervisory Responsibilities: None. Experience, Knowledge, and Skills: Requires BS in microbiology, biology or related science or equivalent experience. 1+ years experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP (membrane filtration, endotoxin and TOC), bacteriostasis and growth promotion assay Experience with GMP, GLP, and FDA regulations and ISO requirements Experience in environmental monitoring of clean room, aseptic media fill evaluation Excellent verbal and written communication skills Proven ability to meet deadlines for testing and reporting Proficient in the use of Microsoft Office Suite including PowerPoint

Salary Range:$60,000.00 To $80,000.00 Annually Summary of Primary Responsibilities: Responsible for all microbiological and some analytical testing of production materials under GMP conditions. Responsible for process and equipment validation (autoclave and depyrognenation oven) in cooperation with Engineering and R&D (New Product Sterility and LAL validation.) Specific Responsibilities: * Perform bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samples * Perform company's purified water and DI water bioburden, endotoxin and TOC testing as per USP requirements * Complete all required documentation according to SOP * Verify work of technicians and assist in training * Review environmental condition of classified areas, maintain database for environmental results of clean room environment and summarize data for annual environmental report * Provide training on environmental compliance issues * Development and validation of new or improved microbiological methods * Writing and/or approving validation protocols, coordinating and/or performing validation and writing and/or approving validation reports * Establishing databases for microbiological and validation data * Performs Internal Audits as scheduled * Other duties and projects as assigned Job Complexity: Works on complex problems requiring in-depth analysis and evaluations of factors, and on assignments that are required to be performed according to defined procedures and practices. Exercises considerable judgment and initiative within broadly defined practices and policies in selecting methods and techniques. Normally receives no instruction on routine work, general instructions on new assignments. Supervisory Responsibilities: None. Experience, Knowledge, and Skills: * Requires BS in microbiology, biology or related science or equivalent experience. * 1+ years experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP (membrane filtration, endotoxin and TOC), bacteriostasis and growth promotion assay * Experience with GMP, GLP, and FDA regulations and ISO requirements * Experience in environmental monitoring of clean room, aseptic media fill evaluation * Excellent verbal and written communication skills * Proven ability to meet deadlines for testing and reporting * Proficient in the use of Microsoft Office Suite including PowerPoint The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law. submit your resume We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

It's not what we make. It's what we make possible and the possibilities at Lifecore are endless! This full-time weekend shift position offers incredible benefits, a three-day work week, competitive pay with a generous weekend shift pay premium, and a company culture focused on development and growth which includes promotion opportunities. The QC Microbiologist I will ensure accurate, reproducible, and timely QC testing in support of manufacturing. They will have the opportunity to: Perform testing on in-process product, final product, and raw materials for routine testing, validation testing, and stability testing Communicate results through appropriate documentation and batch records, statistical analysis and trending Acquire and maintain cleanroom and gowning qualification which include maintaining proper hygiene and meeting physical challenges (balance, flexibility, etc.) that are involved in the gowning process Maintain awareness of and perform all support activities necessary for cleanroom work This position could be a great fit for you if you have a high attention detail and enjoy working in a fast-paced laboratory along with the following: BS in Microbiology or related life science Experience in GMP lab applications Basic understanding of biological technology and methodology Working knowledge of word processing and spreadsheet software Proven ability to work independently as well as function effectively as a team member Proven ability to maintain a high attention to detail Schedule: Friday - Sunday, 6:00am - 6:30pm, work 36 hours - eligible for 40 hours of compensation Starting Salary: $57,000 - $60,000 annual + $100 per pay period shift premium Lifecore offers a highly competitive total rewards package, including: Opportunities to learn and grow with a well-respected company Competitive compensation with annual reviews and a company-wide incentive bonus Benefits that start the first of the month after you join Lifecore as a full-time employee: 3 medical insurance plans to fit your needs and budget including an HSA Plan with a generous company contribution. Low cost dental and vision insurance Short term disability, long term disability and life insurance all 100% company paid 3 weeks PTO in the first year (increases to 4 weeks after just 2 years!) 9 paid company holidays plus 1-2 personal holidays 4 weeks of paid family leave after 1 year of employment Tuition reimbursement 401k plan with company matching contribution Meet Lifecore Biomedical, LLC: Lifecore Biomedical, Inc. (Nasdaq: LFCR) is a fully integrated contract development and manufacturing organization (CDMO) that offers highly differentiated capabilities in the development, fill and finish of sterile injectable pharmaceutical products in syringes, vials, and cartridges, including complex formulations. As a leading manufacturer of premium, injectable-grade hyaluronic acid, Lifecore brings more than 40 years of expertise as a partner for global and emerging biopharmaceutical and biotechnology companies across multiple therapeutic categories.

It's not what we make. It's what we make possible a nd the possibilities at Lifecore are endless!

It's not what we make. It's what we make possible and the possibilities at Lifecore are endless!

We are seeking an analytical chemist with general laboratory experience including creation of standards/spiking mixes, sample preparation, and sample analysis as well as familiarity with GC/MS, FTIR, percent moisture determination, LC-MS/MS, HPLC-UV, and/or Raman analytical platforms. The focus of this role will be on providing technical support to Signature Science's quality assurance (QA) contracts for defense and homeland security programs as well as commercial proficiency testing (PT) programs, including HazMat PT, hemp/cannabis PT, and custom PT programs. The successful candidate will also support internal Signature Science quality programs through maintenance of the quality management system and QA laboratory support. Essential Duties and Responsibilities: Assist with planning and implementation of chemical analysis proficiency tests for methods such as gas chromatograph mass spectrometry (GC/MS), Fourier transform infrared spectroscopy (FTIR), percent moisture determination, liquid chromatography with tandem mass spectrometry (LC-MS/MS), high performance liquid chromatography - ultraviolet (HPLC-UV), and Raman. Activities include developing proficiency test plans, performing laboratory pilot testing, preparing and verifying proficiency test samples, and packaging samples for shipment. Perform laboratory activities related to the preparation and verification of proficiency test samples, as detailed below: o Creation of standards/spiking mixes, o Sample creation, o Sample extraction/dilution, and sample analysis, using techniques such as GC/MS, FTIR, percent moisture determination, LC-MS/MS, HPLC-UV, and Raman. Maintain laboratory equipment and laboratory records. Perform laboratory inventories, purchase laboratory supplies, and maintain appropriate purchasing records. Evaluate special study and proficiency test data, identify data trends and other issues, and help prepare reports. Lead or assist with the validation and/or verification of new methods Contribute to the development and revision of internal and external quality documents based on ISO/IEC 17025, ISO/IEC 17043, ISO 17034, and Clinical Laboratory Improvement Program (CLIP) standards, as applicable. Perform internal audits of Signature Science systems and procedures against relevant internal or external standards such as ISO/IEC 17025, ISO/IEC 17043, and ISO 17034. Regularly communicate with internal laboratory staff to help resolve laboratory or other quality-related issues. Other activities may include: o Assisting client laboratories in preparing for external ISO/IEC 17025 accreditation audits and attend assessments as an advocate for the client laboratory o Communicating with external laboratory staff to help resolve QA, PT, or other quality-related issues o Providing feedback and help prepare auditee corrective actions packets for submission to the accreditation body or certification body o Providing ISO/IEC 17025 training or training on other quality topics to clients o May serve as a task leader on one or more projects Required Knowledge, Skills & Abilities: General chemistry laboratory experience (e.g., creation of standards/spiking mixes, sample extraction/dilution, and sample analysis). Knowledge of and/or experience with GC/MS, FTIR, percent moisture determination, LC-MS/MS, HPLC-UV, and/or Raman analytical platforms. General quality management experience, preferably in an analytical laboratory setting. Proficiency in MS Word, MS Excel, and MS PowerPoint. Strong written and verbal communication skills. Proactive, self-starter Preferred knowledge, skills, and abilities include: Laboratory experience with GC/MS, FTIR, percent moisture determination, LC-MS/MS, HPLC-UV, and/or Raman analytical platforms. Experience assessing data for trends. Analytical laboratory auditing experience. Knowledge and experience with relevant quality standards, including ISO/IEC 17025, ISO/IEC 17043, ISO 17034, and/or CLIP. Ability to lead small teams and ensure accurate and timely submission of project deliverables. Education/Experience: Bachelor degree (or higher) in chemistry, biochemistry, or related field. At least 3 years experience performing analytical chemistry laboratory work Certificates and Licenses: None upon hire Clearance: Candidate must be able to obtain a Secret level security clearance. Supervisory Responsibilities: May serve as a task leader on one or more projects Working Conditions/ Equipment: Ability to work in varying conditions to include: traditional office environments with sedentary extended periods required for voluminous data analysis via office automation; Climate controlled laboratory environments requiring extended periods of standing when performing laboratory analyses, or during audits and SOP observation; Mobile laboratories, subject to wide ranges of temperature and humidity requiring extended periods of standing, stooping or kneeling in confined spaces; conference, classrooms or theaters that involve extended periods of standing for training delivery or command briefings; and outdoors in various weather and lighting conditions including heat, humidity, cold, snow, bright sun, and dark night. Exposure to various chemical and biological materials associated with an analytical lab or facility. Ability to wear required personal protective equipment (PPE) including gloves, coats or gowns, shoe cover, tyvek coveralls, safety glasses, respirators, and/or PAPRs. Subject to medical monitoring based on lab functions. The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. Powered by ExactHire:190938

We are hiring a Powder Formulation Technician. The Powder Formulation Technician will be responsible for formulation of powdered media. 3rd Shift: 9:00 pm- 5:30 am At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world's biggest health challenges. Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you're ready to make an impact, your future belongs with us at FUJIFILM Biosciences. Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Responsibilities: Formulates Powder media formulas per manufacturing protocols utilizing various weighing equipment such as scales and balance. Uses Mettler-Toledo IND780 terminal system in conjunction with the SAP ERP system to ensure correct raw materials assigned in the batch record are weighed at the specified quantity. Suggest changes in departmental procedures and processes (SOPs) as needed. Performs and documents line clearance at the start of each formulation event. Maintains all required logs and associated documentation. Assures that all chemicals are stored and labeled properly. Performs process scale checks on all required equipment including scales and balances. Keeps work area, utensils, tanks, mills, and equipment clean and organized. Ensures that supplies needed such as weigh boats, gloves, lab coats, etc. are well stocked in their designated areas. Orders supplies or informs Lead/Supervisor if supplies need to be ordered. Follows all safety procedures and works in a safe manner including wearing all required personal protective equipment. Understands and follows procedures to ensure that chemicals are handled properly. Good understanding of metric system and its conversions. Follows and actively participates in sustaining the 6S program in the area. Other duties as requested by Lead or Supervisor. Required Skills/Education: High School Diploma or equivalent. Background in medical devices, diagnostics, food/vitamin processing, or pharmaceuticals. 1-2 years of hands on experience General education about chemicals and proper handling (college level science preferred). Working knowledge of metric system. Good understanding of current Good Manufacturing Practices (cGMPs). Ability to speak, read, and write English. Good oral and written communication skills. Salary and Benefits: For California, the base salary range for this position is $19.65 - $25.51 per hour. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.). Medical, Dental, Vision Life Insurance 401k Paid Time Off *#LI-onsite EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (*****************).

J oin Immatics and shape the future of cancer immunotherapy ; one patient at a time! Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. Why Join Us? Innovative Environment: Help to pioneer advancements in cancer immunotherapy. Collaborative Culture: Be part of a diverse team dedicated to your professional growth. Global Impact: Contribute to therapies that make a lasting impact on patients globally. We are seeking a Senior Quality Control Analyst to join our Global Quality Operations team. In this role, the Senior Quality Control Analyst will be responsible for performing bioanalytical, cell-based, and molecular assays to support product release and stability testing within the Quality Control laboratory. The position will also play a key role in method transfer, qualification, and validation activities. FLSA Classification: Salary, Exempt Schedule: 8:00 AM - 5:00 PM; Monday to Friday; On-site Reports to: Quality Control Manager Location: 13203 Murphy Road Suite 100 Stafford, TX 77477 What You'll Do: As a Senior Quality Control Analyst, you will play a key role in supporting our Quality Control Operations: Conduct Tests and Analyze Results: Perform routine and non-routine testing on products and materials to verify compliance with established standards. Collaboration: Manage, in collaboration with other team members, purchasing, receiving, formulating, testing, release of materials and reagents, equipment and assay qualifications and validation. Quality Records: Lead quality documents and processes such as GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc. Documentation: Author and conduct periodic review of procedures. Conduct and document all activities consistent with cGMP/GxP, regulatory filings, and written procedures. Maintain data integrity and logs for equipment. Data Analysis: Ability to analyze complex data sets and interpret results accurately. Able to identity trend and deviations, and take initiative to troubleshoot issues Manage Laboratory Equipment: Perform and oversee the maintenance and calibration of laboratory equipment. Ensure Compliance: Involved in the creation of systems used in quality control to maintain compliance with regulations. Safety: Always demonstrate good safety practices and promote safety awareness. Secondary Functions: Train and support junior analysts. Transport controlled documents, QA-released QC materials and human biological samples. Assist with group tasks scheduling Maintain knowledge of internal procedures and current regulatory requirements Required Experience and Education: BA or BS in any science-related field Minimum five (5) years experience in a regulated laboratory environment MS degree or specialized skill set may substitute for 3 years Experience as a QC personnel in a related field. Experience in aseptic technique, cell culture and either flow cytometry or cell-based assays. Preferred Experience and Education: MS in Biology, Biological Sciences, Laboratory Science, Biochemistry, or Biomedical Science/Engineering Minimum five (5) years experience in a regulated laboratory environment Laboratory skills include a few of the following: visual inspection, flow cytometry, molecular and cell-based assays. Demonstrate technical competence and knowledge in method transfer and assay qualification/validation activities Excellent technical writing and troubleshooting/investigational skills. Demonstrate knowledge of cGMP/ICH/EU regulations and requirements. Experience writing GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc. Experience with LIMS and statistical software is a plus Competencies: Initiative Problem Solving Very detail oriented Strong analytical Technical writing, verbal communication, and interpersonal skills Ability to work Independently and manage multiple projects with aggressive timelines Work Environment: This position works in a typical office and lab environment with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. Other duties performed while outside of office and lab building could involve exposure to manufacturing operations, along with outdoor conditions (including highway traffic) and temperatures. The percentage of working hours spent in a typical office and/or laboratory environment varies based on business needs. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, fumes or airborne particles, pathogens, and toxic or caustic chemicals. The employee can be occasionally exposed to wet and/or humid conditions, risk of electrical shock, sharps, or cuts, while performing tests. This position requires handling of human biological specimens including human peripheral blood and human T cell products, as well as laboratory chemicals Travel required: Less than 10% Minimal Physical demands: Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others. Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder. Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers). Pushing - Exerting force upon an object so that the object moves away from the object. Pulling - Exerting force upon an object so that the object moves toward the force. Sitting - remaining in a sitting position for at least 50% of the time. Standing/Walking - remain on one's feet in an upright position at a workstation. Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles. Work authorization/security clearance requirements: Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment Affirmative Action/EEO statement: Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. What do we offer? At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics Comprehensive Benefits: Competitive rates for Health, Dental, and Vision Insurance 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment. Sick Time Off - 56 hours 12 Paid Holidays 100% Employer-Paid Life Insurance up to at 1x annual salary 100% Employer Paid Short- and Long-Term Disability Coverage 401(k) with Immediate Eligibility & company match… You are eligible for 401(k) plan participation as of your first paycheck. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment. Partially paid Parental Leave for eligible employees. (3 weeks) Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance. Professional Growth: Opportunities to work with leading experts in the field of T-cell immunotherapy. Company provided learning and development opportunities Fast paced, high demand collaborative and dynamic environment.

This position is responsible for manufacturing product by vialing detection/capture antibodies, calibrators, or assembling antibody set products. DUTIES AND RESPONSIBILITIES * Responsible for preparing manufacturing records, dilution and blending of anitbody/calibrator materials, assemble vial sets, and printing of labels as instructed by Standard Operating Procedures (SOP) in order to produce final goods products for MSD customers. * Performs peer review of product labels prior to vialing as the first quality check in the production process. * May operate automated vialing, bottling, labeling, or lyphilizing equipment May handle BSL-2 reagents to produce calibrator products. * Provides input to improve routine manufacturing processes that provide for better quality and quantity of products. * Participates in 5S initiatives by maintaining and improving laboratory tidiness and efficiency. * Completes appropriate documentation to support process and production procedures including data entry and batch records and daily maintenance and documentation of all production equipment * Participates in general laboratory maintenance including maintaining laboratory cleanliness, supplies and equipment to include but not limited to: preparing, maintaining and reporting reagent inventories, maintain pipette calibration schedules, participating in year-end physical inventory, and defrosting freezers. * Specific duties may vary depending upon departmental requirements. EXPERIENCE AND QUALIFICATIONS * Associate's degree in Biology, Chemistry, Biotechnology, Engineering or related field field or equivalent work experience. * Prior manufacturing experience a plus. KNOWLEDGE, SKILLS AND ABILITIES * Demonstrates an aptitude for learning and adhering to standard laboratory techniques and safety precautions. * Basic knowledge of scientific fundamentals. * Basic knowledge of pipetting. * Ability to follow laboratory safety instructions; ability to use protective equipment. * Excellent oral, written communication and interpersonal skills. * Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data. * Proficiency in MS Office Suite. * Ability to multi-task and work productively in a demanding manufacturing environment with changing priorities. * Basic knowledge of cGMP and/or ISO certification highly preferred. * Ability to utilize equipment necessary to perform the essential duties of the job. * Ability to move/lift up to 25 pounds. PHYSICAL DEMANDS * Utilize equipment necessary to perform the job, and lifting up to 25 lbs. * Up to 80% of the day may be spent at a laboratory bench. WORK ENVIRONMENT Standard industrial laboratory environment COMPENSATION SUMMARY: The annual base salary for this position ranges from $45,500 to $66,000. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success. BENEFITS SUMMARY: At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance. EEO/AA STATEMENT: MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please click on the following link: **************************************************************************************** Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.

The Quality Control Microbiologist II is responsible for performing microbiological testing and managing results of incoming raw materials, in-process samples, and final product samples. Review and analyze testing data to ensure internal specifications are in accordance with standard operating procedures requirements. Ensure testing results are accurate, and results are available in a timely manner. Must write and review procedures, reports, and investigations. Performs all functions in accordance with standard operating procedures, all applicable federal and state regulatory and accrediting standards requirements. Requirements Perform microbiology testing including, but not limited to reading of cultures, gram staining, microbial limit test, cell count and cell viability testing, growth promotion testing, and biochemical testing. Support the environmental monitoring program (EM), Stability Program, and the Dose Audit Program. Perform microbial characterization including subcultures of samples, gram stain, biochemical testing, and final identification using VITEK 2. Conduct testing of clean utilities of the facility, including but not limited to performing TOC, pH, and conductivity testing. Review and analyze test results according to internal standard procedures to ensure proper management, tracking, and disposition of materials and products. Performs reviews and approval of routine testing documents. Responsible for reporting and analyzing all variances, errors, and deviations to Quality Management. Maintain proper documentation and trend analysis of QC test results. Perform laboratory cleaning and maintenance of equipment. Maintains the laboratory stock of media, reagents and laboratory supplies. Lead QC validations and supports interdepartmental validations and qualifications that require microbiological testing. Support Write investigations, deviations, and change controls. Manages the implementation of controlled changes and corrective actions. Participate in the on-call weekend schedule. Perform other duties as assigned by QC Management Qualifications Education/Experience: Bachelor's degree in science with at least 3-4 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). Associate's degree in science with at least 4 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). Skills: Excellent interpersonal, verbal, and written communication skills required. Must demonstrate excellent organizational and record-keeping skills. Must be detail oriented with the ability to multi-task in a high-pressure environment. Proficient in Microsoft Office. Working conditions Fast paced, lab-oriented work environment. Evening and weekend work may be required. Physical requirements While performing the duties of this job, the employee is regularly required to sit or stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds. Direct Reports No direct reports. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job any time. VIVEX Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

The Quality Control Microbiologist I is responsible for performing microbiological testing and managing results of incoming raw materials, in-process samples, and final product samples. Review and analyze testing data to ensure internal specifications are met in accordance with standard operating procedures requirements. Ensure testing results are accurate, and results are available in a timely manner. Performs all functions in accordance with standard operating procedures, all applicable federal and state regulatory and accrediting standards requirements. Requirements Perform microbiology testing including, but not limited to reading of cultures, gram staining, microbial limit test, cell count and cell viability testing, growth promotion testing, and biochemical testing. Support the environmental monitoring program (EM), Stability Program, and the Dose Audit Program. Perform microbial characterization including subcultures of samples, gram stain, biochemical testing, and final identification using VITEK 2. Conduct testing of clean utilities of the facility, including but not limited to performing TOC, pH, and conductivity testing. Review and analyze test results according to internal standard procedures to ensure proper management, tracking, and disposition of materials and products Responsible for reporting all variances, errors, and deviations to Quality Management. Maintain proper documentation and trend analysis of QC test results. Perform laboratory cleaning and maintenance of equipment. Maintains the laboratory stock of media, reagents and laboratory supplies. Support validations and qualifications that require microbiological testing. Participate in audits and inspections, accreditation, and licensing activities as needed. Supports investigations, complaints, and deviations contributing to the formulation and implementation of corrective actions. Participate in the on-call weekend schedule. Perform other duties as assigned by QC Management. Qualifications Education/Experience: Bachelor's degree in science with at least 0-2 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). Associate's degree in science with at least 2 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). Required/Preferred Experience: Hands on Environmental Monitoring experience in a regulated GMP environment (cleanroom EM, viable/non-viable monitoring, trend analysis, excursions). Skills: Excellent interpersonal, verbal, and written communication skills required. Must demonstrate excellent organizational and record-keeping skills. Must be detail oriented with the ability to multi-task in a high-pressure environment. Proficient in Microsoft Office. Working conditions Fast pace, lab-oriented work environment. Evening and weekend work may be required. Physical requirements While performing the duties of this job, the employee is regularly required to sit or stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds. Direct Reports No direct reports. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job any time. VIVEX Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. VIVEX Biologics complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.

Description: The Quality Control Microbiologist II is responsible for performing microbiological testing and managing results of incoming raw materials, in-process samples, and final product samples. Review and analyze testing data to ensure internal specifications are in accordance with standard operating procedures requirements. Ensure testing results are accurate, and results are available in a timely manner. Must write and review procedures, reports, and investigations. Performs all functions in accordance with standard operating procedures, all applicable federal and state regulatory and accrediting standards requirements. Requirements: Perform microbiology testing including, but not limited to reading of cultures, gram staining, microbial limit test, cell count and cell viability testing, growth promotion testing, and biochemical testing. Support the environmental monitoring program (EM), Stability Program, and the Dose Audit Program. Perform microbial characterization including subcultures of samples, gram stain, biochemical testing, and final identification using VITEK 2. Conduct testing of clean utilities of the facility, including but not limited to performing TOC, pH, and conductivity testing. Review and analyze test results according to internal standard procedures to ensure proper management, tracking, and disposition of materials and products. Performs reviews and approval of routine testing documents. Responsible for reporting and analyzing all variances, errors, and deviations to Quality Management. Maintain proper documentation and trend analysis of QC test results. Perform laboratory cleaning and maintenance of equipment. Maintains the laboratory stock of media, reagents and laboratory supplies. Lead QC validations and supports interdepartmental validations and qualifications that require microbiological testing. Support Write investigations, deviations, and change controls. Manages the implementation of controlled changes and corrective actions. Participate in the on-call weekend schedule. Perform other duties as assigned by QC Management Qualifications Education/Experience: Bachelor's degree in science with at least 3-4 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). Associate's degree in science with at least 4 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). Skills: Excellent interpersonal, verbal, and written communication skills required. Must demonstrate excellent organizational and record-keeping skills. Must be detail oriented with the ability to multi-task in a high-pressure environment. Proficient in Microsoft Office. Working conditions Fast paced, lab-oriented work environment. Evening and weekend work may be required. Physical requirements While performing the duties of this job, the employee is regularly required to sit or stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds. Direct Reports No direct reports. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job any time. VIVEX Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

We are seeking a self-motivated Chemistry Lab Technician to join our Lab Operations team. In this role you will assist in laboratory confirmatory analysis of biological fluids including urine, oral fluid (saliva) or hair specimens. This role is also responsible for operating, maintaining and troubleshooting various Auto Chemistry instrumentation. Shift: Tues-Sat.? Tues-Friday 4pm-1am, Sat 10am-7pm Salary: $21.00 Primary Responsibilities * Loads, prepares and extracts specimens using various Auto-Chem Instrumentation. * Assist in instrument calibration, QC review, and initial analytical review. * Prepare reagents and buffers as needed. * Assists with maintaining an adequate inventory of laboratory supplies. * Responsible for all record keeping associated with specimen preparation, including following chain of custody handling guidelines and storage requirements. * Conducts safe work practices according to safety protocols, PPE requirements and decontamination procedures. * Responsible to maintain all safeguards as it pertains to Protected health information (PHI). Qualifications * Bachelor?s degree in a science field (Chemistry, Biochemistry, Biology, Microbiology, Pre-med (Biomed), Forensics & Toxicology), required. * Experience as a lab technician, preferred. * Data entry skills via a keyboard (alpha and numeric) required. * Strong eye-hand coordination. * Ability to handle a high-volume environment while maintaining the highest level of quality, required. * Physical demands required to perform critical tasks in this role include standing for long periods of time, lifting up to 25lbs, bending and carrying. Benefits Cordant supports our employees by providing a comprehensive benefits package to eligible staff (per state regulations) that includes: Medical, Dental, Vision Insurance, Flexible Spending Accounts (FSA), Health Savings Accounts (HSA) Paid Time Off (PTO) accruing on day 1, Volunteer Time Off (VTO), Paid Holidays, 401(k) with Company Match, Employee Assistance Program (EAP), Short Term and Long-Term Disability (STD/LTD) and Company Paid Basic Life Insurance.

MAIN JOB RESPONSIBILITIES / COMPETENCIES 1. Thorough knowledge and appropriate implementation of critical production functions such as Manufacture of Collamer Material 2. Assist in the Manufacture of In-Process materials (HEMA, Collagen Solution) as necessary 3. Maintain all equipment (including glassware) used for Collamer Material production 4. Completes required production documentation accurately. 5. Consistently meets quality and productivity targets. 6. Appropriately follows company policies, rules, and regulations. 7. Maintain work area environment in a clean and orderly manner. 8. Other duties as assigned. REQUIREMENTS EDUCATION & TRAINING * Minimum 4 yr Degree; or work experience EXPERIENCE * 2 years experience as a Formulation Technician I or Equivalent experience. * Experience with cleanroom environments preferred SKILLS * Ability to understand and implement general GMP concepts. * Ability to work in a clean/controlled environments. * Capable of learning and performing duties with minimum supervision. * Possess good communication, organizational and math skills. * Ability to read, write and speak English. * Ability to lift up to 25 pounds. * Ability to take direction from lead/supervisor and other management. * Ability to work with chemicals and utilize proper safety equipment. * Ability to follow detailed work instructions precisely and participate in process improvements. Pay range: $22 to 24/ per hour - Final compensation will depend on experience. STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.

This role contains the following responsibilities covering 2nd shift hours (2:00 pm through 10:30 pm), Monday through Friday: The Senior QC Analyst (2nd Shift) will be trained to execute analytical test methods and their corresponding analytical techniques. The core function is composed of completing QC testing for in-process, characterization, release, or stability samples. Additionally, when need arises, Senior QC Analyst will assist with troubleshooting and support In-process Support Associates with STAT samples during 2nd shift. Responsibilities include: In-process, characterization, stability, and/or release testing as assigned. Capabilities include (but not limited to) HPLC, ELISA, qPCR, SoloVPE, other spectrophotometric techniques, capillary electrophoretic techniques, and compendial testing per USP with near-zero error and minimal guidance or direction Execution of method transfer, method qualification, and/or method validation testing performed under protocol Solution preparation Organizes and processes samples according to GxP standards Independent analysis and collation of data to draw conclusions Enter data into control charts and LIMS, if applicable Supports lab investigation and deviation reports Supports implementation of Corrective and Preventive Actions Revises SOPs and technical documents Supports team to troubleshoot testing or project challenges with comfort in presenting and communicating data Tracks department metrics upon request; actively engages in improvement of department metrics Partakes in continuous improvement projects or leading simple improvement projects Ensures state of safety and regulatory audit readiness at all times Maintains work to current Good Manufacturing Practices (cGMP) Ensures Trainer qualification status to expand team matrix Laboratory support - ensures areas are neat, clean, organized, and equipment is functioning Participates in data review activities Duties may include support in STAT testing coordination It is the expectation that this position is required to be onsite full time with a minimum of 75% of time in the laboratory/facility Minimum Requirements: Relevant degree and 4-8 years' biopharmaceutical industry experience, preferably in protein analytics Salary: $63,000-$86,900 KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Oversees logs and procedures and ensures Q.C. and Production are abiding by GMP and GLP company rules set forth by company SOPs. Ensuring things are made right in the first place is the best way of preventing out of specification products. ESSENTIAL DUTIES AND RESPONSIBILITIES: Includes the following, but other duties may be assigned as the company's needs dictate. Reviews and approves the Production filling batch records. Checks and audits the documents for accuracy and GMP compliance during and at the completion of filling. Checks and confirms that the correct components and compounding batch have been set-up and are being used on the appropriate packaging line. Reviews the data reported by the mechanics, machine operators, and line leads to ensure that the information is correct and entered appropriately. Responsible for placing compounded batches and finished goods that do not conform to company specifications into Quarantine status with applicable labeling. Reports any quality issues to Quality management and participates in investigations, as necessary. Performs daily housekeeping audits of the Production area logbooks and reports results to Quality management. Supports GMP training of employees. Participates in Quality System audits as directed by Quality management. Complies with Health, Safety, and Environmental responsibilities for the position. Inspects the production lines to ensure that both Production and Quality control personnel are following the required SOP to perform their jobs. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE: High school diploma or GED (general education degree) and some college (science-based courses preferred). Minimum 6-months of hands-on experience as Quality audit/inspector in cGMP environment; preferably in pharmaceutical, biomedical, or medical device field (regulated industry). Experience with batch record keeping, CAPA initiation, and deviation investigation. Should have experience working on the floor of a manufacturing facility. LANGUAGE SKILLS: Fluent in reading, writing, and speaking the English language, as well as having experience with technical writing (knowing Spanish is a plus). Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from departmental manager/supervisor or other employees. MATHEMATICAL SKILLS: Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. COMPUTER SKILLS: To perform this job successfully, an individual should have knowledge of Database software, Spreadsheet software and Word Processing software. REASONING ABILITY: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit, use hands to finger, handle or feel; and reach with hands and arms. The employee is occasionally required to stand, walk, talk or hear, and taste and smell. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. 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. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles (herbal powders). The noise level in the work environment is usually quiet. Sunrider Manufacturing provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Oversees logs and procedures and ensures Q.C. and Production are abiding by GMP and GLP company rules set forth by company SOPs. Ensuring things are made right in the first place is the best way of preventing out of specification products. ESSENTIAL DUTIES AND RESPONSIBILITIES: Includes the following, but other duties may be assigned as the company's needs dictate. Reviews and approves the Production filling batch records. Checks and audits the documents for accuracy and GMP compliance during and at the completion of filling. Checks and confirms that the correct components and compounding batch have been set-up and are being used on the appropriate packaging line. Reviews the data reported by the mechanics, machine operators, and line leads to ensure that the information is correct and entered appropriately. Responsible for placing compounded batches and finished goods that do not conform to company specifications into Quarantine status with applicable labeling. Reports any quality issues to Quality management and participates in investigations, as necessary. Performs daily housekeeping audits of the Production area logbooks and reports results to Quality management. Supports GMP training of employees. Participates in Quality System audits as directed by Quality management. Complies with Health, Safety, and Environmental responsibilities for the position. Inspects the production lines to ensure that both Production and Quality control personnel are following the required SOP to perform their jobs. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE: High school diploma or GED (general education degree) and some college (science-based courses preferred). Minimum 6-months of hands-on experience as Quality audit/inspector in cGMP environment; preferably in pharmaceutical, biomedical, or medical device field (regulated industry). Experience with batch record keeping, CAPA initiation, and deviation investigation. Should have experience working on the floor of a manufacturing facility. LANGUAGE SKILLS: Fluent in reading, writing, and speaking the English language, as well as having experience with technical writing (knowing Spanish is a plus). Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from departmental manager/supervisor or other employees. MATHEMATICAL SKILLS: Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. COMPUTER SKILLS: To perform this job successfully, an individual should have knowledge of Database software, Spreadsheet software and Word Processing software. REASONING ABILITY: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit, use hands to finger, handle or feel; and reach with hands and arms. The employee is occasionally required to stand, walk, talk or hear, and taste and smell. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. 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. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles (herbal powders). The noise level in the work environment is usually quiet. Sunrider Manufacturing provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.