4,101 Cmc Specialist jobs in the United States

Responsibilities:

• Regulatory Submission: Prepare and submit documents to regulatory authorities, including Investigational New Drug (IND) applications and Abbreviated New Drug Applications (ANDA).
• Compliance Monitoring: Ensure that clinical trials adhere to Good Clinical Practice (GCP) and other relevant regulations.
• Communication: Act as a liaison between regulatory bodies, clinical teams, and external stakeholders to facilitate communication and address any compliance issues.
• Document Management: Maintain and organize essential documents, including study protocols, informed consent forms, and safety reports.
• Risk Assessment: Identify potential regulatory risks and develop strategies to mitigate them throughout the clinical trial process.
• Training and Support: Provide guidance and training to clinical research staff on regulatory requirements and best practices.
• Stay Updated: Keep abreast of changes in regulatory policies and guidelines that may impact clinical research.

Requirements:

• Knowledge of Regulations: In-depth understanding of FDA regulations, ICH guidelines, and other international regulations.
• nalytical Skills: Ability to analyse complex regulatory documents and data.
• ttention to Detail: Meticulous in reviewing documents for accuracy and compliance.
• Communication Skills: Strong written and verbal communication skills for effective interaction with diverse stakeholders.
• Project Management: Ability to manage multiple projects and timelines efficiently.

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

The Document Specialist/Coordinator will be responsible for authoring, managing, and coordinating the documentation related to Chemistry, Manufacturing, and Controls (CMC), Technical Operations, and Manufacturing activities within the Global Supply Chain and Technical Operations organization. This role involves supporting the CMC, Technical Operations, and Manufacturing functions as needed in supporting compliance with quality and regulatory requirements.

Key Responsibilities:

• Organize, maintain, and archive CMC, Technical Operations, and Manufacturing documentation.
  
• Ensure all CMC, Technical Operations, and Manufacturing documentation complies with regulatory and quality guidelines (e.g., FDA, EMA) and company standards.
  
• Collaborate with cross-functional teams (e.g., Quality Assurance, Regulatory Affairs, Global Supply Chain) to gather necessary information and ensure timely completion of CMC documents.
  
• Assist in the preparation of CMC sections of regulatory filings, including INDs, IMPDs, NDAs, and MAAs.
  
• Work with CMC, Technical Operations, and Manufacturing SMEs to ensure documents are accurate, complete and consistent.
  
• Open and coordinate change controls/deviations in QMS.
  
• Provide support to CMC team members on document management systems.
  
• Support internal and external audits and inspections by ensuring availability and integrity of CMC documentation.
  
• Identify opportunities for process improvements in document management and implement best practices.
  

Qualifications:

• Bachelor's degree in Life Sciences (preferably Chemistry), or a related field. Advanced degree preferred.
  
• Minimum of 3 years of experience in CMC documentation within the pharmaceutical industry.
  
• Strong understanding of regulatory requirements for CMC documentation (e.g., FDA, EMA guidelines).
  
• Excellent organizational, communication, and interpersonal skills.
  
• Proficiency and experience with document management systems (i.e. Veeva, Box, and SharePoint) and Microsoft Office Suite.
  
• Working knowledge of change controls, deviation investigations, and GMP requirements.
  
• Excellent attention to detail, organizational, and communication skills.
  
• Ability to work independently and as part of a cross-functional team under tight deadlines.
  
• Working knowledge of ICH guidelines and regulatory writing best practices.
  
• Good technical writing skills.
  

#LI-HYBRID

Pay Range:

In the U.S., the hiring pay range for fully qualified candidates is $34-$56 per hour. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications
  
• We will never request personal information such as banking details until after an official offer has been accepted and verified
  
• We will never request that you purchase equipment or other items when interviewing or hiring
  
• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at
  

Please visit our website at:

Cytokinetics is an Equal Opportunity Employer

**Now Hiring: Quality Control Inspector - 2nd Shift**
**Location:** Winsted, CT 06098
**Pay Rate:** $20.00 per hour
**Schedule: Mon-Fri 3pm-11pm**
+ **Training on 1st Shift** (7am-3:30pm)
+ Transition to **2nd Shift** after training a few weeks **Assignment Type:** Full-time, Temp-Hire
**Position Title: QUALITY CONTROL INSPECTOR**
**Reports to:** Quality Supervisor
**Position Overview:**
We are seeking a dependable and detail-oriented **Quality Control Inspector** to join our team in Winsted, CT. This role is critical to ensuring our products meet the highest quality standards. The position begins with training on 1st shift before transitioning to 2nd shift. If you're quality-focused and eager to grow, we want to hear from you.
**Key Responsibilities:**
+ Perform visual inspections at various magnifications using magnifiers, microscopes, and related tools
+ Ensure all inspection equipment is properly calibrated before use
+ Maintain a clean and organized inspection station
+ Clearly and accurately report inspection results
+ Identify, segregate, and initiate Discrepancy Reports for nonconforming product
+ Comply with stamp control and sample traceability procedures
+ Review and understand new and revised specifications as required
**Requirements:**
+ Previous experience in a **manufacturing or production environment**
+ High school diploma or **GED equivalent**
+ Ability to **sit for 5-7 hours per day**
+ Ability to **walk, push, carry, or lift up to 50 lbs occasionally**
+ General standing and mobility required during shift
+ **No visual color deficiencies** - clear vision is essential to perform inspections accurately
**Why You'll Love This Role:**
+ Hands-on training with skilled quality professionals
+ A clean, safety-first work environment
+ Competitive hourly pay
+ Be part of a company that values precision, teamwork, and growth
**Apply Today!**
If you take pride in accuracy and enjoy working in a detail-driven environment, this could be the perfect role for you. Start your career in quality assurance with a team that supports your growth every step of the way.
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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Hourly Wage: **$23.15 - $6.65 per/hour**
*The actual hourly rate will equal or exceed the required minimum wage applicable to the job location.
Additional compensation includes annual or quarterly performance incentives.
Additional compensation in the form of premiums may be paid in amounts ranging from 0.35 per hour to 3.00 per hour in specific circumstances. Premiums may be based on schedule, facility, season, or specific work performed. Multiple premiums may apply if applicable criteria are met.
Employment Type: **Full-Time**
Available shifts: **Weekday - 1st**
Location
**Supply Chain Grocery #6064**
3470 WINDMILL RD, CLEBURNE, TX, 76033, US
Job Overview
Career opportunities in Administration and Clerical roles include Service Shop and Maintenance Clerk, Quality Assurance, System Operator. Administration roles such as Human Resource Clerk and Office Assistant.
Benefits & perks
At Walmart, we offer competitive pay as well as performance-based incentive awards and other great benefits for a happier mind, body, and wallet. Health benefits include medical, vision and dental coverage. Financial benefits include 401(k), stock purchase and company-paid life insurance. Paid time off benefits include parental leave, family care leave, bereavement, jury duty, and voting. Other benefits include short-term and long-term disability, company discounts, Military Leave Pay, adoption and surrogacy expense reimbursement, and more.
You will also receive PTO and/or PPTO that can be used for vacation, sick leave, holidays, or other purposes. The amount you receive depends on your job classification and length of employment. It will meet or exceed the requirements of paid sick leave laws, where applicable. For information about PTO, see Smart Guide page ( Better U is a Walmart-paid education benefit program for full-time and part-time associates in Walmart and Sam's Club facilities. Programs range from high school completion to bachelor's degrees, including English Language Learning and short-form certificates. Tuition, books, and fees are completely paid for by Walmart.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms. For information about benefits and eligibility, see One.Walmart.com.
Walmart is committed to maintaining a drug-free workplace and has a no tolerance policy regarding the use of illegal drugs and alcohol on the job. This policy applies to all employees and aims to create a safe and productive work environment.
Walmart, Inc. is an Equal Opportunity Employer- By Choice. We believe we are best equipped to help our associates, customers, and the communities we serve live better when we really know them. That means understanding, respecting, and valuing diversity- unique styles, experiences, identities, abilities, ideas and opinions- while being inclusive of all people.

Hourly Wage: **$20.9 - $4.4 per/hour**
*The actual hourly rate will equal or exceed the required minimum wage applicable to the job location.
Additional compensation includes annual or quarterly performance incentives.
Additional compensation in the form of premiums may be paid in amounts ranging from 0.35 per hour to 3.00 per hour in specific circumstances. Premiums may be based on schedule, facility, season, or specific work performed. Multiple premiums may apply if applicable criteria are met.
Employment Type: **Full-Time**
Available shifts: **Weekday - 1st, Weekday - 2nd, Weekend - 5th**
Location
**Supply Chain Grocery #3010**
1065 FORT PRINCE BLVD, WELLFORD, SC, 29385, US
Job Overview
Career opportunities in Administration and Clerical roles include Service Shop and Maintenance Clerk, Quality Assurance, System Operator. Administration roles such as Human Resource Clerk and Office Assistant.
Benefits & perks
At Walmart, we offer competitive pay as well as performance-based incentive awards and other great benefits for a happier mind, body, and wallet. Health benefits include medical, vision and dental coverage. Financial benefits include 401(k), stock purchase and company-paid life insurance. Paid time off benefits include parental leave, family care leave, bereavement, jury duty, and voting. Other benefits include short-term and long-term disability, company discounts, Military Leave Pay, adoption and surrogacy expense reimbursement, and more.
You will also receive PTO and/or PPTO that can be used for vacation, sick leave, holidays, or other purposes. The amount you receive depends on your job classification and length of employment. It will meet or exceed the requirements of paid sick leave laws, where applicable. For information about PTO, see Smart Guide page ( Better U is a Walmart-paid education benefit program for full-time and part-time associates in Walmart and Sam's Club facilities. Programs range from high school completion to bachelor's degrees, including English Language Learning and short-form certificates. Tuition, books, and fees are completely paid for by Walmart.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms. For information about benefits and eligibility, see One.Walmart.com.
Walmart is committed to maintaining a drug-free workplace and has a no tolerance policy regarding the use of illegal drugs and alcohol on the job. This policy applies to all employees and aims to create a safe and productive work environment.
Walmart, Inc. is an Equal Opportunity Employer- By Choice. We believe we are best equipped to help our associates, customers, and the communities we serve live better when we really know them. That means understanding, respecting, and valuing diversity- unique styles, experiences, identities, abilities, ideas and opinions- while being inclusive of all people.

Hourly Wage: **$23.25 - $6.75 per/hour**
*The actual hourly rate will equal or exceed the required minimum wage applicable to the job location.
Additional compensation includes annual or quarterly performance incentives.
Additional compensation in the form of premiums may be paid in amounts ranging from 0.35 per hour to 3.00 per hour in specific circumstances. Premiums may be based on schedule, facility, season, or specific work performed. Multiple premiums may apply if applicable criteria are met.
Employment Type: **Full-Time**
Available shifts: **Weekday - 3rd**
Location
**Supply Chain Grocery #6072**
973 STATE HIGHWAY 30 W, NEW ALBANY, MS, 38652, US
Job Overview
Career opportunities in Administration and Clerical roles include Service Shop and Maintenance Clerk, Quality Assurance, System Operator. Administration roles such as Human Resource Clerk and Office Assistant.
Benefits & perks
At Walmart, we offer competitive pay as well as performance-based incentive awards and other great benefits for a happier mind, body, and wallet. Health benefits include medical, vision and dental coverage. Financial benefits include 401(k), stock purchase and company-paid life insurance. Paid time off benefits include parental leave, family care leave, bereavement, jury duty, and voting. Other benefits include short-term and long-term disability, company discounts, Military Leave Pay, adoption and surrogacy expense reimbursement, and more.
You will also receive PTO and/or PPTO that can be used for vacation, sick leave, holidays, or other purposes. The amount you receive depends on your job classification and length of employment. It will meet or exceed the requirements of paid sick leave laws, where applicable. For information about PTO, see Smart Guide page ( Better U is a Walmart-paid education benefit program for full-time and part-time associates in Walmart and Sam's Club facilities. Programs range from high school completion to bachelor's degrees, including English Language Learning and short-form certificates. Tuition, books, and fees are completely paid for by Walmart.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms. For information about benefits and eligibility, see One.Walmart.com.
Walmart is committed to maintaining a drug-free workplace and has a no tolerance policy regarding the use of illegal drugs and alcohol on the job. This policy applies to all employees and aims to create a safe and productive work environment.
Walmart, Inc. is an Equal Opportunity Employer- By Choice. We believe we are best equipped to help our associates, customers, and the communities we serve live better when we really know them. That means understanding, respecting, and valuing diversity- unique styles, experiences, identities, abilities, ideas and opinions- while being inclusive of all people.

Manpower is hiring for a Quality Control?in Portageville, MO! Our client is looking for a top-notch candidate interested in a long-term career role. This is a great opportunity with a reputable and safe manufacturing company.
**Job Title: Quality Control**
**Location:** **Portageville, MO**
**Pay Range: $15.00 Hrly**
**Shift: 11:00pm - 7:00am**
**What's Needed?**
+ Complete production task in accordance with ISO/TS 16949 based procedures and work instructions
+ Develop competent, multidisciplinary skill sets capable of performing work in the areas of mold, paint, assembly and quality.
+ Knowledge of conveyance systems used in paint
**What's in it for me?**
+ Your job will be interesting and filled with a variety of tasks.
+ You will get to be hands-on and active throughout your day.
+ This is a temp-to-hire opportunity.
+ Weekly pay!
+ Manpower benefits including medical, dental, and 401(k).
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
**?**
**About ManpowerGroup, Parent Company of:?Manpower, Experis, Talent Solutions, and Jefferson Wells**
_ManpowerGroup? (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands -?_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _?-_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th year - all confirming our position as the brand of choice for in-demand talent.
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.

Hourly Wage: **$23.15 - $6.65 per/hour**
*The actual hourly rate will equal or exceed the required minimum wage applicable to the job location.
Additional compensation includes annual or quarterly performance incentives.
Additional compensation in the form of premiums may be paid in amounts ranging from 0.35 per hour to 3.00 per hour in specific circumstances. Premiums may be based on schedule, facility, season, or specific work performed. Multiple premiums may apply if applicable criteria are met.
Employment Type: **Full-Time**
Available shifts: **Weekend - 4th, Weekend - 5th**
Location
**Supply Chain Grocery #8348**
940 E PLEASANT RUN RD, LANCASTER, TX, 75146, US
Job Overview
Career opportunities in Administration and Clerical roles include Service Shop and Maintenance Clerk, Quality Assurance, System Operator. Administration roles such as Human Resource Clerk and Office Assistant.
Benefits & perks
At Walmart, we offer competitive pay as well as performance-based incentive awards and other great benefits for a happier mind, body, and wallet. Health benefits include medical, vision and dental coverage. Financial benefits include 401(k), stock purchase and company-paid life insurance. Paid time off benefits include parental leave, family care leave, bereavement, jury duty, and voting. Other benefits include short-term and long-term disability, company discounts, Military Leave Pay, adoption and surrogacy expense reimbursement, and more.
You will also receive PTO and/or PPTO that can be used for vacation, sick leave, holidays, or other purposes. The amount you receive depends on your job classification and length of employment. It will meet or exceed the requirements of paid sick leave laws, where applicable. For information about PTO, see Smart Guide page ( Better U is a Walmart-paid education benefit program for full-time and part-time associates in Walmart and Sam's Club facilities. Programs range from high school completion to bachelor's degrees, including English Language Learning and short-form certificates. Tuition, books, and fees are completely paid for by Walmart.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms. For information about benefits and eligibility, see One.Walmart.com.
Walmart is committed to maintaining a drug-free workplace and has a no tolerance policy regarding the use of illegal drugs and alcohol on the job. This policy applies to all employees and aims to create a safe and productive work environment.
Walmart, Inc. is an Equal Opportunity Employer- By Choice. We believe we are best equipped to help our associates, customers, and the communities we serve live better when we really know them. That means understanding, respecting, and valuing diversity- unique styles, experiences, identities, abilities, ideas and opinions- while being inclusive of all people.

Adecco is assisting a local client recruiting for Quality Control Technician opportunities in Piscataway, NJ. This is an excellent opportunity to join a winning culture and get your foot in the door with a company that values quality, precision, and innovation in a collaborative lab environment. If Quality Control Technician sounds like something you would be interested in-and you meet the qualifications listed below-apply now!
**Responsibilities for a Quality Control Technician include but are not limited to:**
+ Perform inspections and tests on finished goods and components, including physical and chemical analyses.
+ Maintain accurate documentation and inspection reports in compliance with internal procedures.
+ Support calibration and maintenance of lab equipment to ensure proper functionality.
+ Manage samples per protocol-labeling, storing, and disposing as necessary.
+ Adhere strictly to SOPs, GMPs, and safety guidelines.
+ Report deviations and collaborate across QC, production, and other departments.
+ Contribute to continuous improvement efforts in QC processes.
+ Assist with general lab duties (lifting/sorting boxes, cleaning, etc.).
**Candidates for Quality Control Technician must meet the following requirements to be considered:**
+ Proven ability to follow protocols and work in a regulated environment.
+ Basic knowledge of lab equipment and documentation standards.
+ Strong attention to detail and communication skills.
+ Ability to work independently and with cross-functional teams.
+ Willingness to perform physical tasks such as lifting or sorting materials.
**What's in this Quality Control Technician position for you?**
+ Pay: $26.51/hour
+ Shift: Monday to Friday, 6:45 AM - 2:45 PM
+ Weekly paycheck
+ Dedicated Onboarding Specialist & Recruiter
+ Access to Adecco's Aspire Academy with thousands of free upskilling courses
This Quality Control Technician position is being recruited for by one of our Centralized Delivery Teams and not your local Branch. For instant consideration for this position and other opportunities with Adecco in Piscataway, NJ, apply today!
**Pay Details:** $26.51 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
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+ San Francisco Fair Chance Ordinance