Compliance Associate

1 week ago

Fort Collins, United States Tolmar Full time
Description

Core Hours: Monday - Friday: 6:00am-2:30pm

This position‘s duration will be approximately one year.

Purpose and Scope

The QA Compliance Associate I is responsible for providing the Quality Assurance review of manufacturing batch records in support of product release to ensure compliance in accordance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Practices (cGMPs), FDA and global laws and regulations.

Essential Duties & Responsibilities

  • Perform batch record compilation, review and maintenance.
  • Perform detailed quality assurance review on executed batch records for commercial and development products.
  • Make entries into databases and spreadsheets that support the production schedule and quality indicators.
  • Perform investigation searches on executed batch records to ensure that deviations that apply to the batch record are known and can be assessed for closure by QA Management.
  • Work with various departments to request needed records and correct batch record errors.
  • Compile reviewed batch records into final complete executed batch record to make ready for final QA review for release of the product.
  • Manage released batch records and forward for document scanning.
  • Prioritize workload and coordinate activities to meet and support timely product release and ship schedules.
  • Perform other duties as assigned.

Knowledge, Skills & Abilities

  • Knowledge of cGMPs and other documentation and regulatory requirements.
  • Skill in organization and attention to detail.
  • Skill in effective written and oral communication.
  • Excellent troubleshooting and problem solving skills.
  • Knowledge of computer operations, including proficiency with MS Word, Excel and Access.
  • Ability to work independently
  • Ability to work well with employees at all levels and departments.

Core Values

  • The QA Compliance Associate I is expected to operate within the framework of Tolmar‘s Core Values:
  • Consistently operate with the highest standards of ethics and compliance.
  • Take ownership of your actions, success and setbacks.
  • Respect each other and understand that honest collaboration is at the heart of our company success.
  • Go the extra mile to make things happen.
  • Be committed to all we do and the patients we serve.
  • Embrace change with enthusiasm.
  • Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

  • High School diploma or equivalent required.
  • Associates degree in technical subject preferred. Some college work in technical subjects helpful.
  • Three or more years of experience in the pharmaceutical or medical device industry in a Quality Assurance role.

Working Conditions

  • Conditions are normal for an office environment.

Compensation and Benefits

  • Pay: $25.00 per hour
  • Benefits summary: careers/employee-benefits
    • Please note that due to the temporary nature of this position, not al benefits may apply.

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.



Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor‘s legal duty to furnish information. 41 CFR 60-1.35(c)

  • Associate Athletic Director for Compliance

    2 weeks ago

    Fort Collins, CO, United States NCAA (National Collegiate Athletic Association) Full time

    The Associate Athletic Director for Compliance reports to the University President with an indirect reporting line to the University Chief of Staff and the Director of Athletics (or designee). This position will lead the departmental athletics compliance program by creating, maintaining, and monitoring a compliant environment that results in clear...

  • Investment & Trade Compliance Associate

    3 weeks ago

    Fort Lauderdale, United States A. Solomon Recruits Full time

    My client is seeking an Investment & Trade Compliance Associate to assist their Global Compliance Team in the oversight of compliance of the asset management business and specifically the provisions of relevant securities laws. The successful candidate should be able to monitor client portfolios and perform the daily compliance of the asset management...

  • Utility Associate

    8 months ago

    Collins, United States Wayne-Sanderson Farms Full time

    Primarily responsible for filling in/performing all jobs in assigned area/department in absence of regular worker. Trains new and current associates on jobs in area as needed. Performs all work in compliance with company policies, NCC Animal Welfare Associate, Utility, Manufacturing, Retail

  • Research Associates I or II

    6 days ago

    Fort Collins, Colorado, United States Colorado State University Full time

    **Job Summary:**The Department of Health and Exercise Science at Colorado State University is seeking a temporary research associate to support our faculty in various research projects. As a research associate, you will work closely with the principal investigator and other research associates to conduct experiments, collect data, and analyze results.The...

  • Research Associate

    3 weeks ago

    Fort Collins, United States Inotiv Full time

    Research Associate ILocation : LocationUS-CO-Fort CollinsID2024-5102CategoryResearch and ScienceTypeFull Time - PermanentOverviewThe Research Associate I assists the Study Director with the planning, execution, data tabulation, and reporting of non-Good Laboratory Practices (GLP) and GLP Toxicology, Medical Device and Pharmacokinetic studies.Responsibilities...

  • Senior Research Associate Specialist

    3 weeks ago

    Fort Collins, Colorado, United States Inotiv Full time

    About the Role:We are seeking a highly motivated and detail-oriented Senior Research Associate Specialist to join our team at Inotiv. As a key member of our research group, you will play a crucial role in assisting the Study Director with the planning, execution, data tabulation, and reporting of non-Good Laboratory Practices (GLP) and GLP Toxicology,...

  • Research Associate I

    3 weeks ago

    Fort Collins, United States Inotiv Full time

    Job DescriptionResearch Associate ILocation : LocationUS-CO-Fort CollinsID2024-5102CategoryResearch and ScienceTypeFull Time - PermanentOverviewThe Research Associate I assists the Study Director with the planning, execution, data tabulation, and reporting of non-Good Laboratory Practices (GLP) and GLP Toxicology, Medical Device and Pharmacokinetic...

  • Compliance Support Specialist

    4 weeks ago

    Fort Worth, Texas, United States HTeaO Full time

    **Job Summary**:The Paralegal/Compliance Administrator plays a vital role in ensuring HTeaO's compliance with regulatory and legal standards. This position requires exceptional organizational skills, a proactive approach to compliance tracking, and the ability to manage multiple tasks with attention to detail.**Key Responsibilities:**Legal Documentation and...

  • Associate Director of Scholarship Stewardship

    6 months ago

    Fort Collins, United States Colorado State University Full time

    As a land-grant university CSU, emphasizes the importance of access to education by supporting a vibrant, diverse, and robust scholarship program. The Associate Director of Scholarship Stewardship will help support the success of the scholarship program by enhancing both the donor and recipient experiences. The position aims to enhance the scholarship...

  • Data Compliance Specialist

    6 days ago

    Fort Lupton, Colorado, United States Charm Industrial Full time

    About the RoleThe Carbon Accounting Associate role is a critical position at Charm Industrial, supporting the company's mission to meet its carbon removal goals. This involves ensuring rigorous, transparent, and reliable data collection, reporting, and compliance.This role will drive cross-functional collaboration, focusing on carbon accounting practices,...

  • Cybersecurity Compliance Specialist

    3 weeks ago

    Fort Wayne, Indiana, United States DuCharme McMillen & Associates Inc Full time

    About DuCharme McMillen & Associates IncAs an employee-owned company, DMA prioritizes its employees' growth and well-being. Our commitment to their success is reflected in our certifications, benefits, and work environment.Estimated Salary Range: $70,000 - $90,000 per yearThis role requires a detail-oriented individual to assist with compliance-related...

  • Paralegal/Compliance Administrator

    2 months ago

    Fort Worth, United States HTeaO Full time

    Job Summary: The Paralegal/Compliance Administrator is a vital role that supports the Compliance department in ensuring that the company adheres to regulatory and legal standards. This role requires excellent organizational skills, a proactive approach to compliance tracking, and the ability to manage multiple tasks with attention to detail. The ideal...

  • Warehouse Associate

    1 week ago

    Fort Collins, United States Patterson Full time $14 - $18

    Patterson isn't just a place to work, it's a partner that cares about your success.One of the distinguishing marks of our company is the talented people who embrace the people-first, always advancing, and results-driven culture. Professional growth abounds in this motivating environment. We value the diverse talents and experiences our employees bring to...

  • Warehouse Associate

    1 week ago

    Fort Collins, United States Patterson Full time $14 - $18

    Patterson isn't just a place to work, it's a partner that cares about your success.One of the distinguishing marks of our company is the talented people who embrace the people-first, always advancing, and results-driven culture. Professional growth abounds in this motivating environment. We value the diverse talents and experiences our employees bring to...

  • Customer Service Associate

    2 weeks ago

    Fort Collins, Colorado, United States State Farm Insurance Full time

    About the Role:As a Customer Service Representative at State Farm Insurance, you will be responsible for assisting customers with inquiries, complaints, and policy changes. You will provide accurate and timely information regarding insurance products and services. Your duties will include processing policy applications, renewals, and cancellations, as well...

  • Mortgage Compliance Prefunding Specialist

    3 weeks ago

    Fort Worth, United States Texas Bank Full time

    SUMMARY: The Mortgage Compliance Prefunding Specialist position is responsible for reviewing all mortgage files scheduled to close to ensure file completeness with investor and company guidelines required on a residential mortgage loan. The incumbent in this role is responsible for working with the Mortgage Loan Officer teams to ensure proper disclosure...

  • Dynamic Senior Living Director

    4 weeks ago

    Fort Collins, Colorado, United States Brookdale Fort Collins AL (CO) Full time

    OverviewBrookdale Fort Collins AL (CO) is seeking an experienced Executive Director to lead our team in providing exceptional senior living services. As a key member of our leadership team, you will be responsible for overseeing the day-to-day operations of our community, including associate relations, resident and family engagement, financial performance,...

  • Pharma Operations Compliance Expert

    2 weeks ago

    Fort Lauderdale, Florida, United States Entegee Full time

    Job TitleA Compliance Expert with specialized expertise in pharmaceutical operations is needed for a 3-6 month project.Salary: $40.00 to $65.00 per hourCompany OverviewEntegee specializes in custom automation projects, offering robotic solutions worldwide.Job DescriptionSeeking a Compliance Expert with deep understanding of pharmaceutical operations,...

  • Aviation Regulatory Compliance Specialist

    1 week ago

    Fort Lauderdale, Florida, United States ACR Electronics Inc Full time

    A career at ACR Electronics Inc. offers the opportunity to work in a fast-paced and dynamic environment, where your skills and expertise can make a real difference in the lives of people around the world.We are seeking an experienced Lead Inspector to join our team in Fort Lauderdale. This is a full-time position that requires an FAA Airframe License.The...

  • Banking Center Manager

    2 months ago

    Fort Collins, United States Academy Bank, N.A. Full time

    Summary:A Banking Center Manager I is an expert educator that is responsible for the overall success of the assigned banking center and provides periodic management support for other banking centers. A Banking Center Manager I is responsible for a profitable banking center through sales and promotion of bank products to qualified clients, ethical oversight...