Quality Inspector jobs at West Pharmaceutical Services - 77 jobs
Quality Assurance Technician
West Pharmaceutical Services 4.9
Quality inspector job at West Pharmaceutical Services
Training for this position will be Monday - Friday Day shift. Fourth Quarter 2025 or First Quarter 2026 this position will change to a 2-2-3-2 12 hour day shift.
At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary
Schedule- 12 hour day shift
In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained.
Essential Duties and Responsibilities
Review and approval of metrology reports, where appropriate, for batch release and validation purposes
New product validation, analysis and reporting.
Quality support to Engineering and Production Departments.
Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems.
Liaise with customers and suppliers on new and existing projects.
Receiving and inspection of incoming goods and materials.
Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications.
Maintain good communications both internally and externally.
Ensures that all metrology equipment is correctly calibrated.
Assists shift personnel with quality issues and/or measurement techniques.
Assists in problem resolution with customers.
Perform periodic audits as requested and completes necessary documentation.
Archives quality records, samples and log procedures.
Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.
Batch paperwork review and final decision to release product for shipment.
Additional Responsibilities
Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
Maintain a clean, orderly, and safe workstation and environment at all times.
Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
Exhibit regular, reliable, and punctual attendance.
Perform other duties as assigned based on business needs.
Keep current with new GMP compliance guidance and internal QA procedures
Support new GMP compliance guidance and Data Integrity initiatives #LI-CS1 #LI-Onsite
Education
High School Diploma or GED Required
Preferred Associates degree in Metrology or QA; or 3 years' on the job experience in a plastics manufacturing environment
Work Experience
3 years of job-related experience; in QA/QC and the use of measuring equipment.
Preferred Knowledge, Skills and Abilities
Able to be aware of all relevant standard operating procedures as per Company policy
Support and contribute to Lean Sigma programs and activities towards delivery of the set target
Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
Willingness to learn new and review new analytical techniques
Meet individual and departmental goals as required
Travel Requirements 5%: Up to 13 business days per year Physical Requirements Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.Additional Requirements
Ability to learn, understand, and remember normal tasks.
Ability to hear, speak, and understand conversation in English in a normal tone of voice.
Must maintain the ability to work well with others in a variety of situations.
Must be able to multi-task, work under time constraints, problem solve, and prioritize.
Read and interpret data, information and documents
Work under deadlines with constant interruptions
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.
#LI-ME1
$44k-58k yearly est. 60d+ ago
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Inspector, Packaging (day shift)
Endo 4.7
Rochester, MI jobs
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Summary
Handles and inspects components and filled product in accordance with Current Good Manufacturing Practices, Operating Procedures and Safety Regulations Documents and communicates functions and duties necessary to complete the manufacture of products produced in the Sterile Filling Department.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Operational Performs all tasks as outlined in Batch Cards, SOPs and Job Aids Effectively demonstrates the ability to perform on automated lines Inspects finished product as required Packs-off product into trays and cases. Requires lifting weights of up to 35 lbs. Operates equipment as defined within the labor grade Maintains a smooth flow of production and monitors equipment as assigned 90% Issues Communicates to PMO or Supervisor in a timely manner any equipment or process deviations Continuous Documentation Documents in a timely manner all tasks requiring written records as specified in GMP regulations 10% Compliance Performs all functions in accordance with cGMPs, Corporate regulations, SOPs, and all other relevant regulations and standards Effectively demonstrates and understands the SOPs and job aids pertinent to each task performed Continuous Other Performs other duties as assigned by supervision Continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job High school Diploma or GED from recognized institution or organization Successful completion of certified in house qualification programs 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. Page 2 of 2 Customer Focus - Results Driven - Leadership - Teamwork - Innovation and Continuous Improvement Endo Job Description Template - Revised July 2014 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. 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. Required to reach with hands and arms and frequently required to use hands to finger, handle or feel. Occasionally lift and/or move up to 50 pounds Specific vision abilities required by this job include close vision Frequently exposed to moving mechanical parts Frequently exposed to toxic or caustic chemicals The noise level is moderate Work environment is a production/manufacturing environment Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
$31k-38k yearly est. Auto-Apply 60d+ ago
Operator, Parenteral Visual Inspection (Nights)
Eli Lilly and Company 4.6
Concord, NC jobs
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.
We're looking for people who are determined to make life better for people around the world and embody our company values of Integrity, Excellence, and Respect for People
Position Description
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.
If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity!
During the project phase, the Parenteral (PAR) Operators (Entry to Lead roles) will support start up activities required to bring the Inspection department into service. They will become the experts within their assigned area and educate their team in the proper operation of the facility. The Expert and Lead roles are expected to become the leaders for the PAR equipment and process and will lead the training of new staff. This position may require travel (2-4 week trips and/or 3-9 month short term assignments) domestically with the opportunity for travel internationally to collaborate, train with, and learn from sites who currently produce our medicines.
After project phase is complete, this role will be responsible for ensuring continuous supply of our medicines by; expertly running the process, troubleshooting, and collaborating cross-functionally, and holding all to our safety first / quality always mindset. Senior and Lead Operators will coordinate daily activities to meet capacity plans while developing their own and our team's capabilities.
As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles.
Key Objectives / Deliverables
Integrity
Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.
Excellence
Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor.
Responsible for administering technical training and ensuring all operators are trained to perform tasks.
Operate the equipment and perform activities as required to meet production schedule.
Assists in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs)
Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
Respect for People
Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the PAR areas.
(Lead role) Assist Supervisor in development and performance evaluations of shift operators. Act as backup for Supervisor.
Key liaison between operations and support functions.
Requirements (Education, Experience, Training)
Education, Experience, and Skills
We have several levels open for Operator which are based on the experience and education you bring.
Minimum education: High School Diploma or GED
Ability to effectively communicate (electronically, written and verbal)
Flexibility - the ability to troubleshoot and triage challenges
Computer proficiency (desktop software, MS office).
A valid driver's license
Must pass a vision exam and be free of color blindness
Must be equivalent to 20/20 correctable close vision acuity
Time Commitments and Work Authorization
Must Pass a “fitness for duty” physical exam
In operation, must have the ability to work 6pm to 6am on a 2-2-3 schedule
Ability to work overtime as required
Ability to wear safety equipment (glasses, shoes, gloves, etc)
Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
Depending on the candidate's experience, the position may require a short term assignment of 3, 6, or 9 months domestically or internationally to train and be certified on existing processes and establish global contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Preferred attributes but not required
Experience with, completion of, or understanding of:
(Senior and Lead roles) Leadership and the ability to train / educate team members
STEM degree or certifications
Automated, semi-automated, and/or manual inspection.
Knowledge of current Good Manufacturing Practices (CGMPs)
Experience in operations or manufacturing environments.
Pharmaceutical, medical device or food processing industries
Manufacturing Execution Systems and electronic batch release.
Continuous improvement (Lean, Six Sigma methodologies)
Highly automated equipment (inspection, packaging, filling, assembly, etc)
SAP, Electronic Batch Records
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$17.30 - $38.08
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$29k-33k yearly est. Auto-Apply 10d ago
Product Development Quality Leader
Zoetis 4.9
Kalamazoo, MI jobs
Zoetis's Veterinary Medicine Research and Development (VMRD) Product Quality group is seeking highly skilled, detail-oriented, and forward-thinking Quality Leaders who will be active members of vaccine, biopharma and pharma co-development teams providing input on co-development strategy (clinical/PK supplies, design of experiments, analytical method development and transfer, registration batch manufacture, submission planning, etc.) throughout the lifecycle of a project including transfer to Zoetis Global Manufacturing & Supply (GMS).
Their goal will be to assure that long-term product sustainability is a process design deliverable by guiding co-development teams with a quality mindset. Knowledge from product and process development is the basis for establishing an approach to control of the manufacturing process that results in products with the desired quality attributes. The Quality Leaders will help to ensure that during process/product development, variation, impact of variation and control of variation is understood and well documented. The successful candidate will make sure that the appropriate level of quality and compliance is applied across all aspects of the process design stage of process validation, collaborating with both VMRD and GMS. Quality Leaders will be involved in key decision making and supportive processes of the co-development team such as risk assessments, determination of Critical Process Parameters, Critical Quality Attributes (specifications) and control strategies. The close partnership with GMS will continue across the qualification and verification phases of validation to ensure seamless transition of product quality to commercial manufacturing.
The Quality Leaders will foster a culture of excellence and harmonize practices across diverse projects. They will be responsible for the review and approval of GMP documentation (batch records, protocols, reports, stability, etc.) for each project and for the maintenance and continuous improvement of the VMRD Quality Management System policies in accordance with regulatory requirements, Zoetis standards and industry best practices.
Each Quality Leader will be responsible for supporting multiple projects and interfacing with partner groups in the co-development teams across the organization in both VMRD and GMS. These include global development teams, regulatory, GMS quality, formulation, chemistry, analytical, bioprocess development, PK/PD, clinical, CROs, etc.
Expectation that colleague will adhere to being present on-site ≥50% of the time
Responsibilities:
As part of the core co-development team, represent VMRD Product Quality through product development. Provide strategic input and participate in highly matrixed cross-functional teams with operational leaders to prioritize processes and roadmaps and drive innovation. Collaborate to develop and implement innovative solutions to improve business processes, reduce compliance risk, while driving efficiency.
Interpret and stay updated on relevant regulation and guidelines from health authorities.
Ensure that all processes, documentation, facilities, and products comply with requirements. Assure adherence to appropriate GMP practices with a forward-looking perspective to anticipate and address emerging challenges across the business lines.
Ensure a proactive and adaptive approach to evolving project needs. Champion the implementation of efficient and compliant processes. Foster a culture of quality and continuous improvement.
Use a quality-embedded mindset and practical knowledge of industry, customer requirements, and general business environment to define appropriate actions.
Operate within quality management systems to lead, own, and drive investigations, corrective/preventive actions, and change control activities in the design phase
Partner with Quality Operations in GMS during the qualification and verification phases of product lifecycle to ensure a seamless approach to process transfer and to knowledge management.
Identify opportunities for automation and integrating technological solutions to simplify compliance tasks and improve quality.
Demonstrate resilience in the face of challenges, maintaining composure and guiding the team through periods of change.
Basic Qualifications:
Bachelor's degree
Experience across technical (chemistry, analytical, formulation, bioprocess development, etc) disciplines with a demonstrated track-record of constructive influence on product development teams.
10+ years pharmaceutical industry experience.
Preferred Qualifications:
Masters/Graduate Degree
Quality Operations experience Strong leadership skills.
Ability to work independently at a high level.
Strong interpersonal skills and accountability in day-to-day interactions.
Full time RegularColleague
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.
$100k-128k yearly est. Auto-Apply 60d+ ago
Senior Quality Associate
Aquestive Therapeutics Inc. 4.2
Portage, IN jobs
This position is responsible for ensuring compliance with pharmaceutical industry regulations and standards as well as Company policies and procedures. This position supports ongoing quality programs across development and commercialization of products manufactured by the Company. The Sr. Quality Associate is a leader and mentor within the quality organization.
Responsibilities:
Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration/marketing authorization and all other requirements by reviewing manufacturing and laboratory testing records, investigations, non-conformances and out-of-specifications and analyzing cumulatively.
Provides Quality leadership a summary of findings for any batch that does not meet standard requirements for final disposition.
Provide batch disposition and subsequent release to market and/or marketing authorization holder, and issuance of Certificate of Analysis/Conformance according to country specific requirements
Manages internal process for batch release, working closely with Quality Control, Manufacturing and Supply Chain.
Responsible for communicating batch release status externally to partners, triaging questions and organizing the provision of, and providing responses in a timely manner.
Coordinate activities associated with batch release, ensuring corrections are completed and associated batch documentation and investigations and events are closed out.
Compiles and documents monthly metrics, quarterly reports, and ad-hoc reports and data analysis of reports.
Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA)
Review, consult, and approve validations and equipment/instrument qualifications (IQ, OQ, PQ, etc.)
Author, review and approve risk assessments.
Act as a quality representative on internal product teams, including development of products.
Oversee quality system functional processes, such as Change Control.
Will be assigned duties and responsibilities within the Quality System/Unit; specific duties will depend on the assignment and experience of the individual and may include any of the following: coordination/evaluation for Change Control, reviewing Annual Product Reviews, review and approval of validation documents, Events/Deviations/Investigations, evaluating effective CAPA, Product Complaints/Adverse Events, Labeling, Supplier Quality, authoring review and/or approval of standard Quality System documentation (SOPs, Forms, reports, etc.), conducting risk assessments, providing agency and partner audit support, etc.
Qualifications:
BS degree preferably in chemistry, biochemistry, pharmacy or related science field
Minimum 5+ years-experience in pharmaceutical or biotechnology industry required.
Previous experience in providing pharmaceutical Drug Product review and release.
Demonstrated knowledge of GMPs and other regulatory requirements for the manufacture, testing, and release of pharmaceutical
ASQ Certification preferred.
Knowledge and understanding of CFR 210, 211 regulations and ability to apply
Ability to make sound, independent quality decisions.
Demonstrates high levels of values and integrity.
Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement and be a champion of change.
Excellent verbal and written communication skills both internally and externally.
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
$47k-77k yearly est. 26d ago
Senior Quality Associate
Aquestive Therapeutics, Inc. 4.2
Portage, IN jobs
This position is responsible for ensuring compliance with pharmaceutical industry regulations and standards as well as Company policies and procedures. This position supports ongoing quality programs across development and commercialization of products manufactured by the Company. The Sr. Quality Associate is a leader and mentor within the quality organization.
Responsibilities:
* Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration/marketing authorization and all other requirements by reviewing manufacturing and laboratory testing records, investigations, non-conformances and out-of-specifications and analyzing cumulatively.
* Provides Quality leadership a summary of findings for any batch that does not meet standard requirements for final disposition.
* Provide batch disposition and subsequent release to market and/or marketing authorization holder, and issuance of Certificate of Analysis/Conformance according to country specific requirements
* Manages internal process for batch release, working closely with Quality Control, Manufacturing and Supply Chain.
* Responsible for communicating batch release status externally to partners, triaging questions and organizing the provision of, and providing responses in a timely manner.
* Coordinate activities associated with batch release, ensuring corrections are completed and associated batch documentation and investigations and events are closed out.
* Compiles and documents monthly metrics, quarterly reports, and ad-hoc reports and data analysis of reports.
* Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA)
* Review, consult, and approve validations and equipment/instrument qualifications (IQ, OQ, PQ, etc.)
* Author, review and approve risk assessments.
* Act as a quality representative on internal product teams, including development of products.
* Oversee quality system functional processes, such as Change Control.
* Will be assigned duties and responsibilities within the Quality System/Unit; specific duties will depend on the assignment and experience of the individual and may include any of the following: coordination/evaluation for Change Control, reviewing Annual Product Reviews, review and approval of validation documents, Events/Deviations/Investigations, evaluating effective CAPA, Product Complaints/Adverse Events, Labeling, Supplier Quality, authoring review and/or approval of standard Quality System documentation (SOPs, Forms, reports, etc.), conducting risk assessments, providing agency and partner audit support, etc.
Qualifications:
* BS degree preferably in chemistry, biochemistry, pharmacy or related science field
* Minimum 5+ years-experience in pharmaceutical or biotechnology industry required.
* Previous experience in providing pharmaceutical Drug Product review and release.
* Demonstrated knowledge of GMPs and other regulatory requirements for the manufacture, testing, and release of pharmaceutical
* ASQ Certification preferred.
* Knowledge and understanding of CFR 210, 211 regulations and ability to apply
* Ability to make sound, independent quality decisions.
* Demonstrates high levels of values and integrity.
* Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement and be a champion of change.
* Excellent verbal and written communication skills both internally and externally.
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
$47k-77k yearly est. 56d ago
Senior Quality Associate
Aquestive Therapeutics 4.2
Portage, IN jobs
This position is responsible for ensuring compliance with pharmaceutical industry regulations and standards as well as Company policies and procedures. This position supports ongoing quality programs across development and commercialization of products manufactured by the Company. The Sr. Quality Associate is a leader and mentor within the quality organization.
Responsibilities:
Responsible for verifying all batches manufactured are compliant with Good Manufacturing Practices 21 CFR 210 and 211, product registration/marketing authorization and all other requirements by reviewing manufacturing and laboratory testing records, investigations, non-conformances and out-of-specifications and analyzing cumulatively.
Provides Quality leadership a summary of findings for any batch that does not meet standard requirements for final disposition.
Provide batch disposition and subsequent release to market and/or marketing authorization holder, and issuance of Certificate of Analysis/Conformance according to country specific requirements
Manages internal process for batch release, working closely with Quality Control, Manufacturing and Supply Chain.
Responsible for communicating batch release status externally to partners, triaging questions and organizing the provision of, and providing responses in a timely manner.
Coordinate activities associated with batch release, ensuring corrections are completed and associated batch documentation and investigations and events are closed out.
Compiles and documents monthly metrics, quarterly reports, and ad-hoc reports and data analysis of reports.
Provide inputs to process validation activities and process risk decisions (PVMP/PFMEA)
Review, consult, and approve validations and equipment/instrument qualifications (IQ, OQ, PQ, etc.)
Author, review and approve risk assessments.
Act as a quality representative on internal product teams, including development of products.
Oversee quality system functional processes, such as Change Control.
Will be assigned duties and responsibilities within the Quality System/Unit; specific duties will depend on the assignment and experience of the individual and may include any of the following: coordination/evaluation for Change Control, reviewing Annual Product Reviews, review and approval of validation documents, Events/Deviations/Investigations, evaluating effective CAPA, Product Complaints/Adverse Events, Labeling, Supplier Quality, authoring review and/or approval of standard Quality System documentation (SOPs, Forms, reports, etc.), conducting risk assessments, providing agency and partner audit support, etc.
Qualifications:
BS degree preferably in chemistry, biochemistry, pharmacy or related science field
Minimum 5+ years-experience in pharmaceutical or biotechnology industry required.
Previous experience in providing pharmaceutical Drug Product review and release.
Demonstrated knowledge of GMPs and other regulatory requirements for the manufacture, testing, and release of pharmaceutical
ASQ Certification preferred.
Knowledge and understanding of CFR 210, 211 regulations and ability to apply
Ability to make sound, independent quality decisions.
Demonstrates high levels of values and integrity.
Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement and be a champion of change.
Excellent verbal and written communication skills both internally and externally.
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
$47k-77k yearly est. 55d ago
Quality Control Lab Intern
Zoetis 4.9
Kalamazoo, MI jobs
States considered: MI
Role Description:
This role will support QC release testing in the GMS-Kalamazoo lab. Exact duties may depend on selected candidates experience and the needs of the unit. The role will provide the selected candidate with an excellent introduction to GMP lab practices and the pharmaceutical industry.
Quality Control lab intern
Location: Kalamazoo, MI
Internship Summary:
This internship offers hands-on experience in QC (Quality Control) release testing within the GMS-Kalamazoo laboratory. The selected intern will support the lab team in ensuring product quality and compliance, gaining exposure to essential GMP (Good Manufacturing Practices) laboratory procedures and the broader pharmaceutical industry. This internship is an excellent starting point for those considering a career in pharmaceutical quality, laboratory science, or GMP-regulated industries
.
Internship Job Duties:
Receipt of QC samples from Operations and Distribution Throughout the QC Lab.
Stocking laboratory with necessary supplies.
Handling laboratory waste in a safe and compliant manner.
Using laboratory glassware washing machine.
May be trained in analytical sample preparation if skills allow
Internship Qualifications:
Pursuing a bachelors degree in chemistry or related field
Must work well in a team environment
The following hourly pay rates reflect the anticipated base pay for this position:
If the selected candidate is a student pursuing an Associate-level degree: $16.00 per hour
If the selected candidate is a student pursuing an Undergraduate-level degree: $22.00 per hour
If the selected candidate is a student pursing a Graduate-level degree: $32.50 per hour
If the selected candidate is a student pursuing a Doctorate-level degree: $36.00 per hour
The following hourly pay rates reflect the anticipated base pay for this position if a selected candidate were to be located in California, Connecticut, District of Columbia, Illinois (Chicago area), Massachusetts, New Jersey, New York, Washington (Seattle area):
Student pursuing an Associate-level degree: $17.00 per hour
Student pursuing an Undergraduate-level degree: $24.20 per hour
Student pursing a Graduate-level degree: $36.40 per hour
Student pursuing a Doctorate-level degree: $40.30 per hour
Full time Intern (Trainee) 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.
$16-40.3 hourly Auto-Apply 40d ago
Quality Control Lab Intern
Zoetis 4.9
Kalamazoo, MI jobs
Kalamazoo - Portage Road
States considered: MI
Role Description:
This role will support QC release testing in the GMS-Kalamazoo lab. Exact duties may depend on selected candidates experience and the needs of the unit. The role will provide the selected candidate with an excellent introduction to GMP lab practices and the pharmaceutical industry.
Quality Control lab intern
Location: Kalamazoo, MI
Internship Summary:
This internship offers hands-on experience in QC (Quality Control) release testing within the GMS-Kalamazoo laboratory. The selected intern will support the lab team in ensuring product quality and compliance, gaining exposure to essential GMP (Good Manufacturing Practices) laboratory procedures and the broader pharmaceutical industry. This internship is an excellent starting point for those considering a career in pharmaceutical quality, laboratory science, or GMP-regulated industries
.
Internship Job Duties:
Receipt of QC samples from Operations and Distribution Throughout the QC Lab.
Stocking laboratory with necessary supplies.
Handling laboratory waste in a safe and compliant manner.
Using laboratory glassware washing machine.
May be trained in analytical sample preparation if skills allow
Internship Qualifications:
Pursuing a bachelors degree in chemistry or related field
Must work well in a team environment
The following hourly pay rates reflect the anticipated base pay for this position:
If the selected candidate is a student pursuing an Associate-level degree: $16.00 per hour
If the selected candidate is a student pursuing an Undergraduate-level degree: $22.00 per hour
If the selected candidate is a student pursing a Graduate-level degree: $32.50 per hour
If the selected candidate is a student pursuing a Doctorate-level degree: $36.00 per hour
The following hourly pay rates reflect the anticipated base pay for this position if a selected candidate were to be located in California, Connecticut, District of Columbia, Illinois (Chicago area), Massachusetts, New Jersey, New York, Washington (Seattle area):
Student pursuing an Associate-level degree: $17.00 per hour
Student pursuing an Undergraduate-level degree: $24.20 per hour
Student pursing a Graduate-level degree: $36.40 per hour
Student pursuing a Doctorate-level degree: $40.30 per hour
Zoetis is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
$16-40.3 hourly Auto-Apply 12d ago
Quality Control Technician
The Pharmacy Hub 4.3
Miami Gardens, FL jobs
About Us
At The Pharmacy Hub, we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver essential products directly to patients. Our expertise allows us to seamlessly distribute pharmaceuticals, medical devices, and other healthcare products to consumers, ensuring greater accessibility and convenience.
Core Values
The Pharmacy Hub is dedicated to breaking barriers in healthcare by championing access, intervention and affordability.
Customer-first mindset - we develop strong partnerships with telehealth platforms and healthcare companies to enhance access and understand their specific needs
Innovation for intervention in care - we develop advanced compounding solutions and products to better support patient health outcomes
Continuous improvement - we continuously improve our processes and offerings through intelligent, honest and transparent practices to deliver cost-effective solutions that truly benefit our clients and their patients.
You will play a pivotal role in maintaining these values and contributing to the company's mission of redefining healthcare delivery through superior pharmacy services.
Job Summary
We are seeking a detail-oriented Quality Control Technician to support quality assurance and compliance activities within a non-sterile compounding pharmacy environment. This role supports day-to-day quality control functions, documentation accuracy, and regulatory compliance related to compounded preparations, controlled substances, and pharmacy operations.
Key Responsibilities
Perform routine quality control checks in a non-sterile compounding environment
Verify compounding documentation, batch records, logs, and labels for accuracy and completeness.
Assist with tracking deviations, errors, or quality issues related to compounded preparations.
Assit with CAPA activities by collecting data, maintaining logs, and confirming that corrective actions are completed
Maintain accurate and organized quality and compliance records.
Assist with internal audits, inspections, and preparation of supporting documentation.
Work closely with pharmacists, compounding technicians, and compliance staff.
Follow and reinforce quality assurance and documentation standards.
Participate in quality, safety, and compounding-related training.
Collect and document quality data related to compounding operations and pharmacy workflows.
Assist in identifying trends or recurring issues and escalate concerns to the Quality team.
Support basic reporting and tracking of quality metrics.
Qualifications
High School Diploma or GED.
1-2 years of experience in a compounding pharmacy, pharmaceutical lab, healthcare, or regulated production environment
Strong attention to detail and ability to follow written procedures
Basic understanding of quality control principles and regulated workflows.
Hands-on experience with non-sterile compounding.
Familiarity with USP , FDA guidance, and state pharmacy regulations.
Experience supporting quality assurance or compliance functions
What We Offer
Competitive salary.
Bonus program based on productivity and efficiency.
Flexible scheduling options.
Opportunities for growth in a rapidly expanding telepharmacy practice.
Collaborative and innovative work environment focused on patient safety and compliance.
Work Schedule
Evening: 2:30 p.m. - 11:00 p.m
Overnight: 9:00 p.m. - 6:00 a.m
This is a full-time position, working 40 hours per week, Monday through Friday
This is a 100% onsite role; remote or hybrid work is not available.
The hourly rate will vary based on experience
Pay Range$20-$25 USD
Benefits:
401(k) with up to 4% matching
Medical, dental, vision and life insurance
Paid time off
Paid public holidays
At The Pharmacy Hub, we don't just offer jobs-we offer opportunities for career growth and development. We take pride in our fast-paced, team-driven culture and are committed to supporting our employees in achieving success.
If you're ready to join a company that values hard work, dedication, and teamwork, apply today! We look forward to welcoming you to The Pharmacy Hub and working together to deliver top-tier pharmacy fulfillment solutions.
$20-25 hourly Auto-Apply 3d ago
Quality Control Technician
The Pharmacy Hub 4.3
Miami Gardens, FL jobs
Job DescriptionAbout Us
At The Pharmacy Hub, we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver essential products directly to patients. Our expertise allows us to seamlessly distribute pharmaceuticals, medical devices, and other healthcare products to consumers, ensuring greater accessibility and convenience.
Core Values
The Pharmacy Hub is dedicated to breaking barriers in healthcare by championing access, intervention and affordability.
Customer-first mindset - we develop strong partnerships with telehealth platforms and healthcare companies to enhance access and understand their specific needs
Innovation for intervention in care - we develop advanced compounding solutions and products to better support patient health outcomes
Continuous improvement - we continuously improve our processes and offerings through intelligent, honest and transparent practices to deliver cost-effective solutions that truly benefit our clients and their patients.
You will play a pivotal role in maintaining these values and contributing to the company's mission of redefining healthcare delivery through superior pharmacy services.
Job Summary
We are seeking a detail-oriented Quality Control Technician to support quality assurance and compliance activities within a non-sterile compounding pharmacy environment. This role supports day-to-day quality control functions, documentation accuracy, and regulatory compliance related to compounded preparations, controlled substances, and pharmacy operations.
Key Responsibilities
Perform routine quality control checks in a non-sterile compounding environment
Verify compounding documentation, batch records, logs, and labels for accuracy and completeness.
Assist with tracking deviations, errors, or quality issues related to compounded preparations.
Assit with CAPA activities by collecting data, maintaining logs, and confirming that corrective actions are completed
Maintain accurate and organized quality and compliance records.
Assist with internal audits, inspections, and preparation of supporting documentation.
Work closely with pharmacists, compounding technicians, and compliance staff.
Follow and reinforce quality assurance and documentation standards.
Participate in quality, safety, and compounding-related training.
Collect and document quality data related to compounding operations and pharmacy workflows.
Assist in identifying trends or recurring issues and escalate concerns to the Quality team.
Support basic reporting and tracking of quality metrics.
Qualifications
High School Diploma or GED.
1-2 years of experience in a compounding pharmacy, pharmaceutical lab, healthcare, or regulated production environment
Strong attention to detail and ability to follow written procedures
Basic understanding of quality control principles and regulated workflows.
Hands-on experience with non-sterile compounding.
Familiarity with USP , FDA guidance, and state pharmacy regulations.
Experience supporting quality assurance or compliance functions
What We Offer
Competitive salary.
Bonus program based on productivity and efficiency.
Flexible scheduling options.
Opportunities for growth in a rapidly expanding telepharmacy practice.
Collaborative and innovative work environment focused on patient safety and compliance.
Work Schedule
Evening: 2:30 p.m. - 11:00 p.m
Overnight: 9:00 p.m. - 6:00 a.m
This is a full-time position, working 40 hours per week, Monday through Friday
This is a 100% onsite role; remote or hybrid work is not available.
The hourly rate will vary based on experience
Pay Range$20-$25 USD
Benefits:
401(k) with up to 4% matching
Medical, dental, vision and life insurance
Paid time off
Paid public holidays
At The Pharmacy Hub, we don't just offer jobs-we offer opportunities for career growth and development. We take pride in our fast-paced, team-driven culture and are committed to supporting our employees in achieving success.
If you're ready to join a company that values hard work, dedication, and teamwork, apply today! We look forward to welcoming you to The Pharmacy Hub and working together to deliver top-tier pharmacy fulfillment solutions.
$20-25 hourly 17d ago
QA Molding Inspector
BVI 3.5
Sarasota, FL jobs
Job Requisition Name QA Molding Inspector Job Requisition No VN8350 USA - Sarasota Worker Basis Full Time Worker Type Employee Contract Type Permanent Applications Close Date Oct 31, 2030 Purpose As a Quality Assurance Technician, you will participate in the plant's quality assurance program and ensure that manufacturing projects and processes meet all quality control standards.
* Read and comprehend instructions and follow established procedures
* Select components according to specifications and required schedule
* Check output to ensure the highest quality
* Maintain equipment in good condition
* Keep records of production quantities and time; record all information on tracking sheets and in the database
* Report issues, malfunctions, or defective parts
* Assist with coordinating overall quality specifications and standards for processes and finished products
* Inspect molded blanks
* Good understanding of quality control principles
* Good verbal and written communication skills
* Excellent hand-eye coordination and physical condition
* Dependable and detail-oriented
* Ability to establish and maintain effective working relationships with coworkers, managers, and client
BVI is refocusing the future of vision.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products) and PhysIOL (Premium IOLs), and spans more than 90 countries.
We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept - taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at ******************
$28k-42k yearly est. 60d+ ago
QA Inspector - TEMP
Noven Pharmaceuticals 4.6
Miami, FL jobs
Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP's, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards/procedures.
Responsibilities
Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel.
Approve components for in-process operations.
Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations.
Document all work activity in appropriate batch records, forms, and logs to ensure accuracy and compliance.
Sample in-process items, and finished products. Perform required inspections and testing of in-process items and finished products. Process and distribute samples to different departments.
Review records for cGMP compliance for accuracy and thoroughness.
Inform management of problems, failures and deviations from established internal and regulatory standards.
Apply disposition sticker to components and in-process materials.
Issue QA Alerts whenever any questionable component, in-process material or product is identified at any stage of production or storage.
Perform swab and Rodac Plate sampling as required.
Perform transactions in JD Edwards when required.
Qualifications
Competencies:
Education / Experience:
High school diploma or equivalent. Basic computer skills required. Basic math skills required (i.e., calculating %, addition, subtraction, multiplication, division). Ability to read, write, communicate and follow instructions (verbal and written) in English is required.
Judgment / Decision Making:
Duties performed within a framework of departmental or functional protocol requiring a minimal degree of original thinking.
Work Environment:
Majority of time spent at manufacturing plants with exposure to machines with moving parts airborne products, chemicals, muscular strain and noise. Carelessness could result in minor injury. May handle or work with laminates and units containing a Class II Controlled Substance.
Ability to work second and third shift, if required. Ability to work Saturday and/or Sunday, if required.
Physical Demands:
Regularly required to stand for more than one hour at a time; occasionally lifts and carries objects weighing up to 50 pounds. Visual acuity and manual dexterity required to proofread documents and operate computer.
$25k-38k yearly est. Auto-Apply 17d ago
Quality Technician II (Production)
Niowave 3.5
Lansing, MI jobs
Essential Functions
Monitor and maintain the state of inventory, quality, equipment, maintenance, calibration and facilities and ensure they comply with QS and cGMP requirements.
Drive quality and compliance, adhering to all Quality Systems documentation requirements and establishing/supporting plans to exceed Niowave's goals for Quality, including Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and financial objectives.
Support internal and external audits.
Support validation of test methods, monitoring processes, and equipment.
Support production teams in product/material hold, release, disposition, and traceability assessments, and implement improvements to reduce recurring deviations that lead to rework or scrap.
Support new product introduction (NPI) quality activities including prototype testing, process validation, and technology transfer ensure successful product launches.
Collaborate with cross-functional teams to support and solve production and quality challenges.
Collect, monitor, analyze and communicate data to provide insight on quality metrics set by the management team.
$28k-34k yearly est. 60d+ ago
Quality Technician II
Niowave 3.5
Lansing, MI jobs
Summary/objective The Quality Technician II plays a pivotal role in ensuring the effective, efficient, compliant, and proactive support of new product launches and the continuous quality of existing products. The Quality Technician loves details and precision. This role finds standardized work in which deviation could cause an undesirable outcome to be invigorating. Analyzing processes and results to control variations and discussing when improvements would best be introduced is a desirable pastime. Words that describe the Quality Tech are dedicated, efficient, and someone who contributes to making the workday fly by with engaging conversation and team comradery.
$28k-34k yearly est. 60d+ ago
Quality Control Technician
BD Systems 4.5
Tucson, AZ jobs
Summary•The Quality Control Technician primary functions are to assure sterilization operations meet the quality system requirements, product is released to sterilization and shipping after review of documentation and assisting core team with quality issues.
•This position will also provide training, guidance and input on quality issues to the sterilization floor. This position will also audit compliance to the quality policy and procedures.
•The incumbent will participate in continuous improvement and other plant initiatives as needed in support of business goals.Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Primary Responsibilities:
Performs review of sterilization documentation
Releases product to the next stage of shipping
Follows up on sterilization process issues/findings with appropriate parties, support investigation and suggest corrective actions.
Initiate and/or respond to correction and preventive action reports. Document quality system failures and improvement activities.
Conduct routine product and process audits to assure compliance to the quality system.
Perform complete inspection of product according to applicable specifications.
Reports issues to the Supervisor Sterilization Assurance
Responsible for internal documentation updates in SAP when applicable.
Document all inspections as required
Update all reports and databases as required for reporting and tracking purposes
Possess knowledge of Quality System Regulations and control charting defect trends in product quality.
Ensure sterilization associates are properly trained in documented inspection techniques, methods, work instructions
Trend quality metrics and take action to address problems and achieve departmental objectives
Attend, actively participate in, and successfully complete training sessions as needed + specified.
Other duties as assigned (supporting site initiatives, internal or external audits, as part of audit team members)
Additionally:
Support and act as Lead point person for audit and/or change control on Laboratory. Provide information in a timely manner, with relevant system evidence (e.g., Master data export, direct screen sharing with auditors, etc.).
Achieve safety, quality & manufacturing/sterilization shared goals through successful delivery of key business objectives and metrics.
Safety:
Participate fully to achieve the department's safety goals.
Maintain a clean and safe work environment.
Take responsibility for own safety.
Hold self-accountable to follow all safety policies & procedures
Debrief accidents & implement solutions to eliminate root cause.
Hold team members to safety standards/regulations & policies.
Education and Experience:
High School diploma or GED + 2 years of previous quality experience
May have additional certificates and/or bachelor's degree in technology, Engineering, Business, or a closely related field.
Experience with Quality SAP Everest
Computer Skills Excel, Word
High degree of discipline and demonstrates attention to detail.
Proven organizational skills and ability to plan + organize work efficiently.
Good understanding of requirements, QSRs, GLPs, ISO, FDA Guidelines, as well as any other regulations
Strong verbal, communication and interpersonal skills are required: capacity to listen and understand users and stakeholder's expectations
Must be able to work independently, but work in team environment as need it, give and receive feedback.
Demonstrates personal drive and accountability to meet deadlines per project plan.
Demonstrates ability to solve problems, effectively manages risks and/or escalates as needed within established governance framework, strong sense of urgency.
Ability to provide operational support and autonomously address questions / inquiries from various plant (site) associates.
Maintains professional working knowledge and key skills expertise current (up to date).
Travel:
Travel may be required for training and/or development purposes and based on business need.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit **********************
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
#earlycareer
Required Skills
Optional Skills
.
Primary Work LocationUSA AZ - Tucson - Valencia RoadAdditional LocationsWork Shift
$35k-47k yearly est. Auto-Apply 51d ago
Quality Control Lab Technician
Corium Innovations 4.5
Grand Rapids, MI jobs
Corium Innovations is seeking a QC Lab Technician who will contribute to lab audit readiness by routinely managing lab samples as they move through login, testing and release. This position also performs a variety of basic physical inspections on raw materials, in-process and finished product samples according to standard operating procedures and sample testing plans. Your most Innovative career move is here! At Corium Innovations, we've led the way in innovating drug delivery technologies for millions of patients whose GI systems just can't tolerate pills, who can't remember to take their meds as directed, or who have needle-phobia. This is only the beginning! There's so much more to deliver, and we need YOU to do it! Our Purpose is to create, develop and manufacture innovative healthcare products for partners that deliver superior value to patients. Our Goal is to be the best-in-class specialty CDMO through the use of innovative technologies and superior execution. Our Company Values are core to our positive and people-centric culture which inspires all of us to come to work every day on behalf of our people, our partners, our customers, and our patients. Through our four core values, we put people first and create opportunities to make each day better than the last.
Celebrate Individuals: We're looking for talent who will celebrate the uniqueness of each of our team members by encouraging everyone to bring their authentic self to work.
Successful Together: We believe we're better together, so we prioritize teamwork as we work to achieve our shared vision knowing each one of us has an important role to play.
Embrace Innovation: We embrace new challenges and opportunities while encouraging creative thinking and innovative solutions to best meet the needs of our people and our partners.
Pride in Ownership: We take pride in owning our progress and successes, feeling empowered to pursue our growth to reach our full potential. And we hope you will too!
Responsibilities:
Perform sample login and assist with sampling and handling of a variety of raw materials, in process and finished goods.
Perform a variety of basic physical inspections on raw materials, in-process and finished product samples per standard operating procedures and sample testing plans.
Create material documentation including Worksheets, Batch Record Summary Sheets, and Quality Order Cover Sheets.
Retain raw materials and finished products.
Inventory management for all reagents, standards, inventory, and consumables including stocking and replacement.
Routine water testing management at Contract Lab (purchase orders, sample submission and CL documents).
Create purchase orders and tracking.
Chromatographic data management and archiving.
Testing requests and submission management and entry into SharePoint for tracking and testing initiation.
Glassware washing.
Identify improvements, provide recommendations and implement approved solutions related to new and current methods, processes and procedures.
Qualifications:
High school diploma or GED.
0-1 years of relevant experience.
Ability to maintain accurate records.
Attention to detail.
Proficient computer skills including Microsoft Software Products.
Benefits:
Highly competitive benefits program including medical, dental, vision, flexible spending accounts, life insurance, disability insurance, and employee assistance program.
401(k) retirement savings account with a company match and immediate vesting.
12 paid holidays.
Competitive paid vacation plan plus ~1 additional week of paid time off for our annual holiday shutdown.
$32k-43k yearly est. 5d ago
Internship - Quality Compliance
AM General 4.6
Mishawaka, IN jobs
At AM General our Quality Interns support vehicle manufacturing operation by assisting with activities aligned to the Quality Management System (QMS) in accordance with ISO and IATF requirements. The roles provide multi-faceted exposure to supplier quality, compliance, and product inspection and process verification across the manufacturing lifecycle. The intern supports documentation, monitoring, and verification of quality requirements from incoming supplier materials through in-process controls and final product release, while collaborating cross-functionally with Quality, Manufacturing, Engineering, and Supply Chain teams to support conformity to customer, regulatory, and internal quality standards.
PRINCIPLE DUTIES AND RESPONSIBILITIES
Support internal and external quality audits in alignment with IATF 16949 and applicable customer and regulatory requirements.
Assist with audit planning, preparation, execution support, and follow-up activities, including corrective action tracking and documentation.
Support Management Review activities by collecting, organizing, and summarizing required inputs (e.g., audit results, KPIs, nonconformances, risks, and improvement actions).
Assist in maintaining and updating Quality Management System (QMS) documentation to ensure ongoing compliance with IATF 16949 standards.
Support analysis of audit findings, nonconformances, and systemic issues to identify trends and improvement opportunities.
Participate in cross-functional reviews related to quality planning, compliance, and continuous improvement initiatives.
Gain on-the-job experience and exposure to automotive quality tools and methodologies, including AIAG Core Tools, APQP, PPAP, Lean Six Sigma, and IATF 16949 requirements.
Assist with data collection, reporting, and presentation of quality metrics used for compliance monitoring and management review.
KNOWLEDGE AND SKILLS
Currently enrolled in an accredited college or university, with junior or senior standing preferred
Pursuing a bachelor's degree in Manufacturing, Mechanical, Electrical Engineering, or a related engineering discipline.
Proficient in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
Exposure to or a basic understanding of ISO/IATF preferred
Strong analytical, organizational, and problem-solving capabilities.
Ability to clearly and accurately document technical and quality-related information.
Effective written and verbal communication skills.
Demonstrated ability to work collaboratively in a cross-functional, production-focused environment.
High level of professionalism, reliability, and attention to detail.
Interest in quality systems, program management, production processes, and vehicle integration.
$29k-38k yearly est. 5d ago
QC Tech II
Endo Pharmaceuticals Inc. 4.7
Raleigh, NC jobs
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
The Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. She/he will typically work on a rotating shift schedule.
Job Description
ESSENTIAL FUNCTIONS:
Performs in process testing for internal customers.
Performs finished goods, returned goods, and stability testing for external customers as needed.
Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques.
Performs specified analysis on all finished goods using approved written procedures and proper laboratory techniques as needed.
Maintains accurate and precise records of all laboratory analysis using appropriate Mallinckrodt recordkeeping system.
Troubleshoots and performs routine maintenance on laboratory instrumentation.
Prepares all standards and reagents needed for proper execution of analytical methods and procedures.
Prioritizes and plans workload to meet all internal and external customer needs for maximum efficiency and accuracy.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Assists in any non-routine analytical work needed to solve plant problems.
Works on solving problems and implementing improvements in a teaming environment.
Uses problem solving skills to help with failure investigations and testing problems.
Aids in performing any non-routine quality control related tasks such as resampling, raw material testing, and performing analysis needed to validate methods and equipment.
Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
Assists with training others as needed.
Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS:
Education:
Associates of Science (AS) or Bachelor of Science (BS) or equivalent life science degree preferred. Appropriate experience may be a suitable replacement for degree.
Experience:
1 - 3 years laboratory experience in a pharmaceutical manufacturing operation preferred. Working knowledge of cGMP is a plus.
Expected Skills/Qualifications:
Other Skills/Competencies:
Must be able to perform basic mathematical calculations.
Familiarity with basic laboratory procedures, equipment, and computer key punching.
Sound and correct technical judgments are required during routine analysis.
High degree of concentration is required.
Ability to differentiate colors, as demonstrated by passing a test designed to identify color blindness (such as the Ishihara test). If testing criteria are not met with
uncorrected vision, the use of color correcting glasses may be used as long as testing criteria are met while using them.
Functional/Technical Skills, Priority Setting, Written Communication
Customer Focus, Organizing
RELATIONSHIP WITH OTHERS/ SCOPE:
Laboratory technicians are responsible for communicating any uncompleted work to the next shift, as well as any immediate priorities.
Majority of work is performed independently without direct supervision. Non-routine results, observations, or analytical requests are brought to the attention of the appropriate management personnel.
Reports to Quality Testing and Release Manager.
Frequent interact with operators, engineers, and Quality management for reporting routine analytical results. Communication may be though radio, telephone, email, or in person.
Incorrect or inaccurate analyses can result in possible shipment of reject drug items to Mallinckrodt customers.
Customer-requested specifications and Mallinckrodt methods of analysis are considered confidential for marketing purposes.
Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks. Laboratory employees must be able to work effectively under these conditions.
Completes all required Compliance trainings in a timely manner.
WORKING CONDITIONS:
Most work is performed in a well-equipped analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments.
Boxes of solvents, compressed gas cylinders, old records, and reserve samples are stored in areas outside the laboratory and may require lifting and transporting to the laboratory area.
Exposure to fugitive emissions of chemicals typical for chemical operations.
Normal dexterity is required for routine handling of laboratory glassware and instruments. Colors must be well-visualized and slight differences in volumes of liquids in appropriate glassware distinguished.
Must be able to wear the required personal protective equipment (PPE), such as hard-hat, steel-toe shoes, safety glasses, and other equipment as deemed necessary by EH&S, leadership team, corporate, or safety guidelines for the position.
Must be able to work a rotating12 hour shift schedule of (7pm-7am / 7am-7pm) in addition to occasional overtime as needed.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
$29k-38k yearly est. Auto-Apply 60d ago
Quality Control Technician
Elanco 4.9
Clinton, IN jobs
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role: Quality Control Technician
As a Quality Control Technician, you will be part of the Clinton Laboratories Quality organization supporting laboratory testing activities for oral solid dose medications. In this role, you'll assist with sample handling, routine lab testing, and documentation to ensure products meet quality and regulatory standards. You'll also help maintain lab equipment, follow standard operating procedures, and contribute to continuous improvement efforts within the lab. Experience with dissolution or solid oral dose testing is beneficial but not required; training will be provided.
This posting will offer a one-time sign on bonus of $2,500!
Your Responsibilities:
Prepare, handle, and label samples to support quality control testing activities in accordance with GMP requirements.
Perform basic laboratory tasks such as weighing, measuring, and recording data following written procedures.
Maintain and clean laboratory equipment and work areas to ensure readiness and compliance.
Document test data and observations accurately and promptly in accordance with company procedures.
Support laboratory investigations and contribute to process and safety improvement initiatives.
What You Need to Succeed (minimum qualifications):
Education: High School Diploma or equivalent required; Associate's degree in a scientific field preferred.
Required Experience: Hands-on laboratory or manufacturing experience, ideally within a GMP or quality-focused environment.
Top 2 skills: Strong attention to detail and comfort working in a laboratory setting following written procedures.
What will give you a competitive edge (preferred qualifications):
Experience with oral solid dose testing methods such as dissolution or disintegration.
Proficiency with Microsoft Word, Excel, and laboratory informatics systems.
Strong written and verbal communication skills.
Ability to handle multiple priorities while maintaining accuracy and compliance.
Experience working in a GMP or manufacturing environment.
Additional Information:
Location: Clinton Laboratories - Clinton, IN - Onsite manufacturing laboratory environment (PPE required; exposure to allergens possible).
Shifts: Rotation 12-Hour Day Shift (5:45-6:00 likely shift)
This position is a fixed duration employee with a one-year contract, annually renewable for up to 4 years with a potential for a full-time position, based on individual performance and business needs.
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Up to 6% 401K matching
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
$53k-64k yearly est. Auto-Apply 60d+ ago
Learn more about West Pharmaceutical Services jobs