8,384 Qc Analyst jobs in the United States

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

EQUAL OPPORTUNITY EMPLOYER

Corden Pharma 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. Corden Pharma embraces fair hiring practices.

SUMMARY

Performs all technician tasks accurately and efficiently without supervision. Initiates expert technical advice to customers and completes all tasks in the Technician Training Manual. Maintains a high level of housekeeping and attention to detail.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Run routine samples of raw materials, intermediates, and final products. Test special request samples from plants, tech center, or process chemists
• Perform equipment calibration, titrant standardization, and standard validation as required
• Identify and correct problems with instruments in QC lab. Identify and communicate problems and solutions related to process, procedure, and materials to QC Chemist. Researches and takes corrective action on anomalous test results
• Maintain cleanliness and organization of lab by following safety, regulatory, and chemical hygiene policies including GLPs and GMPs
• Perform daily record keeping on SAP and LIMS, enter status changes for raw materials, initiate incident reports, and issue approval-for-use tags
• Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste
• Attend and participate in QC Team meetings. Develop team skills

LEADERSHIP & BUDGET RESPONSIBILITIES

None.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

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

Bachelor's Degree (BA) from 4-year college or university; or 1-year related experience and/or training; or equivalent combination of education and experience. GMP and lab equipment experience preferred.

LANGUAGE SKILLS

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

MATHEMATICAL SKILLS

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

REASONING ABILITY

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

CERTIFICATES, LICENSES, REGISTRATIONS

None.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to work with hands and talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 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 occasionally exposed to fumes or airborne particles, low levels of toxic or caustic chemicals, and outside weather conditions. The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

• Strong math, reading, and comprehension skills
• Analytical skills and knowledge of general or organic chemistry
• Mechanical aptitude with lab equipment
• Support Senior level QC staff with general lab duties
• Preform basic methods on test samples
• Good communication skills and computer skills
• Commitment to QEH&S Principles
• Ability to work closely with team members to a common goal
• Attention to detail
• Ability to work on 12 hour rotating shifts, night or day; weekends and holidays required

SALARY

Actual pay will be based on your skills and experience.

BENEFITS

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
• Accident Plan
• Critical Illness
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft
• Life Insurance
• Paid Maternity/Paternity Leave
• Tuition Reimbursement
• Wellness Program
• Vacation - Three Weeks 1st Year
• Vision Insurance

**QC Analyst II**
Manufacturing
Chicago, IL, US
Pay Rate Low: 30 | Pay Rate High: 33.65
+ Added - 14/04/2025
Apply for Job
Our client, a global leader in biopharma R&D and manufacturing, is seeking an experienced **QC Analyst II** to support upstream/downstream manufacturing operations.
**QC Analyst II**
+ **Pay** : $29-33/hr
+ **Hours:** 1st shift M-F
+ **Terms:** 6 month contract-to-hire
**Key Responsibilities:**
+ Perform analytical testing for in-process, release, and stability studies.
+ Support OOS investigations, deviations, CAPAs, and audits.
+ Collaborate with cross-functional teams on projects and equipment maintenance.
+ Author and revise SOPs, QC methods, and reports.
+ Train junior analysts and support regulatory inspection readiness.
**Qualifications:**
+ BS in biotech, biochem, or related field + 5 yrs QC lab exp.(MS + 3 yrs or PhD + 2 yrs also considered)
+ cGMP lab experience required.
+ Strong background in protein chemistry and analytical troubleshooting.
**Technical Skills:**
+ Proficient with HPLC, SDS-PAGE, ELISA, CE, bioassays, and compendial methods.
+ Experience with regulatory filings and inspection prep (e.g., PAI).
**Additional Info:**
+ Office/lab split; some travel may be required.
+ Fast-paced environment; must meet tight deadlines.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH
#LI-DNP:
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Perform quality control testing of Plasma samples and Pools, processing Red Blood Cells and Units with minimal supervision. Uses discretion and professional judgement in assessing data, verifying results, and assuring quality control. Calculates and correlates test results, troubleshoots and resolves testing and instrument problems. Advises supervisor and or management about deviations and unfamiliar problems. Uses knowledge of cGMP and corporate policies and routine problems.
Primary responsibilities for role:
+ Performs laboratory tests including routine and specialized testing for contracts and customers in compliance with GMP and established procedures.
+ Perform instrument calibration or qualification according to written procedures.
+ Perform instrument troubleshooting including performing minor repairs of equipment/instruments and contacting supplier when necessary following all normal procedures. Manages reagent inventory as assigned. Provides support and oversight maintaining cleanliness and organization of storage areas.
+ Able to prepare reagents with ability to utilize the equipment for such preparation.
+ Maintain thorough and up-to-date knowledge of all related Standard Operating Procedures (SOPs) for the lab.
+ Run specialized computer programs for designated assignments: Excel, e-mail, Word, LIMs, and SA
+ Utilize cGMP practices in documentation and execution of job functions.
+ May be trained and assigned to provide oversight for RBC area and monitor the inventory of frozen red blood cells, and monitor the whole blood units as they are available for freezing.
+ Perform additional miscellaneous lab support tasks as assigned
+ Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
**Additional Responsibilities** Individual must be flexible and able to multi-task. Frequent contact with Manufacturing, Facilities, QA and Receiving responsibilities. Frequent contact with management and outside vendors.
**Knowledge, Skills, and Abilities** Familiarity with chemical, biochemical, and/or microbiological testing. The individual should have experience in one or more of the following analytical instrumentation: HPLC, GC, UV/Vis spectrophotometer, IR spectroscopy, and/or total airborne and viable airborne particulate counters. Immunoassay instrumentation. The individual should be flexible and be able to handle multiple priorities. Able to use personal computer for data entry. Perform math calculations involving dilutions, fractions, decimals and percentages. Understand and follow instructions, record information, find solutions to practical problems or request assistance. Good communication skills, detail-orientated, and able to work well with others.
**Education** B.S. in Chemistry, Biochemistry, Molecular Biology, Biology, or related science discipline for lab.
**Experience** At least 0-3 years of experience in laboratory setting. Work in a regulated environment (FDA, EPA, etc.) is preferred but not required.
**Occupational Demands** Exposure to infectious material (human source products), toxic chemicals, chemical fumes, and odors, electrical hazards, temperature extremes when going to and from coolers and freezers. 15-20% utilizing desk and personal computer using sign and finger dexterity. 70-75% Lab bench either sitting or standing. 10% of the time lifting, carrying, pushing, pulling chemicals, samples, and supplies weighing 30-50 lbs.
BENEFITS:
We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us!
#biomatusa
**Location:** **NORTH AMERICA : USA : FL-Boca Raton** **:** **USBOCLA - RPSTO**
Learn more about Grifols ( ID:** 531615
**Type:** Regular Full-Time
**Job Category:** Others

**QC Analyst II**
Laboratory
Middlesex County, NJ, US
Pay Rate Low: 75000 | Pay Rate High: 8000
+ Added - 07/05/2025
Apply for Job
**Position Summary**
The **QC Analyst II** will perform analytical testing and data review in support of late-stage clinical and commercial small molecule and biosimilar products within cGMP-compliant laboratories. This person will effectively perform and troubleshoot a range of techniques, including HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based bioassays.
**Essential Duties & Responsibilities**
+ Perform analytical testing to support in-process, release, raw material, and stability programs.
+ Ensure compliance with cGMP regulations, quality systems, and applicable ICH/regulatory guidelines.
+ Participate in the investigation and documentation of Out-of-Specification (OOS) results, deviations, and corrective and preventive action (CAPA) plans.
+ Collaborate across departments to support project advancement, equipment maintenance, and the creation of technical documents and reports.
+ Conduct root cause analyses as part of laboratory investigations and assist in closing quality events.
+ Support regulatory and internal audits as needed.
+ Perform additional duties as assigned.
+ Adhere to all company policies and procedures.
**Position Requirements and Qualifications**
**Education:**
+ Bachelor's degree in biotechnology, biochemistry, chemistry, or a related field
+ Minimum of **3+ years** of experience
**Experience:**
+ Hands-on experience working in a cGMP-compliant laboratory.
+ **Proficient in analytical techniques such as HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based assays.**
+ Familiarity with preparing regulatory submissions and data packages for interactions with regulatory agencies (e.g., FDA).
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

**QC Analyst (Chemistry)**
Quality Control
Wilmington, OH, US
Pay Rate Low: 25 | Pay Rate High: 30
+ Added - 14/08/2025
Apply for Job
_Our client, a global leader in the pharmaceutical manufacturing industry, is seeking a QC Analyst to join their team!_
**- Pay: $25-30/hr ($25/hr for entry level/recent graduate)**
**- Shift: 1st shift M-F**
**GENERAL DESCRIPTION:**
The QC Analyst I performs testing of samples submitted to the laboratory in a cGMP compliant manner, as well as according to approved written procedures. The QC Analyst I may be required to write or revise SOPs, analytical procedures, or other analytical documentation at the discretion of quality control supervisory staff.
**KEY DUTIES:**
+ Perform testing in accordance with written procedures (i.e. USP/EP/JP grade)
+ Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices.
+ Processing of electronic data using procedures that ensure data integrity and security.
+ Ship samples to contract testing facilities.
+ Entry of test results from contract laboratories
+ Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations.
+ Transcribe results onto analysis reports.
+ Perform daily standardization and performance verifications on laboratory equipment.
+ Comply with site-wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
+ Identify deviations to written procedures.
+ Disposal of laboratory waste on an as needed basis.
+ Identify and report unsafe conditions within the laboratory.
+ Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation; perform investigative testing.
**SKILLS/ABILITIES:**
+ Ability to perform routine analysis, such as wet chemistry and operate basic laboratory equipment.
+ Understands paperwork review process.
+ Ability to follow written procedures and exhibit excellent documentation practices.
+ Basic laboratory knowledge and skills
+ analytical techniques in wet chemistry/chromatography
+ Practical experience with various types of laboratory instrumentation
+ Troubleshooting skills with analytical methodology and instrumentation.
+ Technical writing skills
+ Employee must be able to pass a vision exam prior to employment and annually thereafter.
**PERSONAL ATTRIBUTES:**
+ Proactively achieves results for the best of the organization.
+ Willingness to learn new things.
+ Ability to function in a small company atmosphere.
+ Ability to cope with a rapidly changing work environment.
+ Commitment to teamwork.
+ Commitment to continuous improvement in all areas.
+ Ability to focus attention to details and ensure high quality work.
+ Ability to work safely; seek out and encourage safe practices
+ Responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills
**EDUCATION AND EXPERIENCE:**
+ Bachelors Degree in Chemistry with 0-2 years of laboratory experience. Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed.
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
**Job Summary**
**The Microbial Solutions site in Charleston, SC is seeking a Quality Control Analyst.**
This role will, ensure the quality and integrity of product by testing incoming materials, excipients and final product. Perform environmental monitoring of LAL (Limulus Amebocyte Lysate) and Crude Lysate production areas to ensure appropriate conditions are maintained. Perform Crude Lysate recovery procedures during the Bleeding Season.
**The Quality Control Analyst will be responsible for the following:**
Ensuring the quality and integrity of product by testing PTS cartridges, Limulus Amebocyte Lysate (LAL), incoming materials, and excipients.
Perform Crude Lysate recovery procedures during the Horseshoe Crab Bleeding Season (Summer Months).
Long-Term Stability monitoring of samples.
Using technical writing to perform investigations and complete exception records.
Attention to detail in all aspects of work is essential.
**Job Qualifications**
+ Bachelor's degree (B.A./B.S.).
+ An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Computer literacy must include word processing, spreadsheet and Technical Writing.
+ One year of experience with GMP products.
+ Prior experience with laboratory operations and auditing.
**Compensation Data**
The pay range for this position is $22-24 per hour USD. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
**Competencies** Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.
**About Microbial Solutions**
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.
**About Charles River**
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.
At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.
**Equal Employment Opportunity**
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit

**Quality Control Analyst - Microbiology (Senior Analyst I)**
Schedule: Monday-Friday, 8:00 AM-5:00 PM
Contract Length: 4 months
Pay: $35-$40/hour (depending on experience)
A leading biotech organization is seeking a **Senior Microbiology QC Analyst** to support routine and investigational testing, environmental monitoring, data review, and implementation of GMP-compliant lab support systems. This role is hands-on in the lab and requires strong technical and operational knowledge of microbiological methods.
**Key Responsibilities:**
+ Perform cGMP microbial testing, including endotoxin, bioburden, and environmental monitoring
+ Review raw data, perform peer or technical reviews, and authorize samples
+ Lead and document lab investigations (IA, OOS, AR) with minimal guidance
+ Author, review, and approve SOPs, technical reports, and validation documents
+ Execute and support operational systems such as equipment calibration, data integrity, sample tracking, and LIMS
+ Perform phase-appropriate method validation and provide data for regulatory filings and inspections
+ Lead and support CAPA and continuous improvement initiatives
**Qualifications:**
+ Bachelor's degree in Microbiology or a related field
+ 3+ years of experience in a cGMP/GxP environment
+ Hands-on experience with bioburden, endotoxin, environmental monitoring, and facility qualification
+ Experience authoring and reviewing SOPs and technical documentation
+ Strong organizational and communication skills
+ Self-motivated with the ability to thrive in a fast-paced, independent setting
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Quality
**Job Sub** **Function:**
Quality Control
**Job Category:**
Professional
**All Job Posting Locations:**
Wilson, North Carolina, United States of America
**Job Description:**
We are currently seeking a highly qualified individual to join our team as a QC Analyst (Analytical Instrument and Lab Systems) at our new Large Molecule Drug Substance Manufacturing facility in Wilson North Carolina (BioNC). In this key role, you will be responsible for laboratory equipment lifecycle management and CSV support, among others.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at Job Duties and Responsibilities:
+ Participate in the qualification of analytical equipment for related testing functions, for example, IQ/OQ/PQ of HPLC, Spectrophotometry, Endotoxin, Cell Culture and Total Organic Carbon equipment.
+ Author SOP's, Work Instructions and protocols.
+ Responsible for the quality control laboratory equipment lifecycle management and CSV support.
+ Participate in activities to introduce technologies and computer base applications to a new site, for example eLIMS/iLABS, SDMS, Empower and SoftMax Pro, to improve laboratory efficiency and promote a culture of Innovation.
+ Interact with the QC Global organization for the different center of excellence for equipment and information technologies.
+ The resolution of unexpected complex compliance or lab instrument and system issues as they arise
Qualifications:
+ Bachelor's Degree in Chemistry, Biochemistry, Micro or science related field with 4+ years related experience in biopharmaceutical or pharmaceutical industry. And/or an equivalent combination of education and experience.
+ Working knowledge of regulatory requirements, policies and guidelines. Experience with Quality Control document reviews and regulatory inspection processes.
+ Working knowledge of laboratory systems.
+ Strong technical knowledge in and experience with QC analytical equipment is required.
+ Knowledge of cGMP regulations and FDA/EU guidance is required.
Other Requirements:
+ An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
+ Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.
+ Proven ability to manage multiple priorities and work independently with minimal supervision.
+ Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
+ Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
+ The ability to work in a team environment and interact with all levels of the organization.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource.