Quality Assurance Document Control Associate

4 weeks ago

Conshohocken, United States Madrigal Pharmaceuticals Corporation Full time
Job DescriptionJob DescriptionThe Quality Assurance Document Control Associate will assist with the management, organization, and maintenance of all quality-related documentation within the organization. This role ensures that all documents meet regulatory standards and are easily accessible for audits and reviews. The candidate will work closely with various departments to ensure that documentation practices comply with internal and external quality standards.

The candidate will have a strong attention to detail, excellent organizational skills, and an understanding of quality assurance principles. Experience with Electronic Document Management Systems (EDMS), such as Veeva Quality Vault, is preferred but not required.  To be considered for this position, you must have a BS/BA degree in life sciences or a related field and have 0-5 years of experience in Document Control.

This position reports into the Senior Manager, Document Control & Training

Position Responsibilities: 
  • Maintain all documents related to the manufacturing processes, including but not limited to executed batch records and Certificates of Analysis, within the EDMS
  • Create batches within the electronic Quality Management System (QMS) and track and upload documents required for batch disposition
  • Upload external documents to the EDMS for archival
  • Follow policies, SOPs, and work instructions to support the document change control process, assign effective dates and training workflows, and archive documents
  • Individual may assist in developing, managing, and maintaining Madrigal Standard Operating Procedures (SOPs), work instructions, protocols, and policies
  • Participate in periodic reviews of documents within the electronic document system to ensure formatting complies with current templates
  • Manage document lifecycle, including creation, revision, approval, distribution, and archiving
  • Assist with the creation of document control metrics, reports and dashboards
  • Work in preparing and organizing documentation for internal and external audits
  • Assist users with document related activities in the EDMS
  • Assist departments with offsite archival of documents and maintain full traceability
  • Maintain confidentiality and security of all documents and information
  • Communicate effectively with team members and management to provide updates on document control activities
  • Manages internal quality improvement initiatives: evaluate internal processes, and suggest/design/implement improvements
  • Provides clerical and administrative support related to documentation processes and systems to include reviewing for conformance to document templates and format
  • Pre-approves and routes documents for review and approval in Veeva QualityDocs.
  • Responsible for filing and maintenance of GxP controlled documents and records. Ensures files are accurate and easily retrievable
  • Provides additional support and assistance on tasks and projects as directed by management
  • Operates as an effective liaison to internal corporate cross-functional areas, CMC/QA consultants, and external partners/contractors
  • Participate in quality improvement initiatives and projects
  • Stay updated on industry best practices and regulatory changes related to quality assurance documentation and maintain required knowledge of applicable regulations, guidelines, and company standards and procedures
Qualifications and Skills Required:
  • BS/BA, with 0-5 years' experience, preferably in pharmaceutical and/or biotech environment in document control and management
  • Experience with Veeva specifically Quality Docs, Training and QMS modules
  • Proficiency in MS Word, Excel, Power Point, and DocuSign Part 11
  • Candidate will have knowledge of GXPs, especially Good Documentation Practices and a good understanding of GMPs
  • Excellent organizational and time management skills
  • Strong attention to detail and accuracy
  • Effective communication and interpersonal skills
  • Knowledge and experience in development, and/or reviews of policies and procedures (i.e., policy documents and SOPs)
  • Knowledge of FDA regulations and ICH Guidelines in the pharmaceutical and/or biotech manufacturing environment
Working Conditions:
  • Office environment (partially remote)
Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
 

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.

Powered by JazzHR

v563pSOVIQ

  • Quality Assurance Specialist

    5 days ago

    Conshohocken, Pennsylvania, United States Sharp Corporation Full time

    Job SummarySharp Corporation is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesEnsure adherence to and enforcement of Good Manufacturing Practices (GMP) compliance throughout our...

  • Quality Assurance Auditor for Contamination Control

    2 weeks ago

    Conshohocken, Pennsylvania, United States PharmaLex Full time

    JOIN OUR CONSULTANT NETWORKPharmaLex is a dynamic and expanding consulting firm dedicated to the Healthcare sector. We are currently experiencing a surge in demand for specialists in Contamination Control Audits, and we aim to enhance our consultant network in anticipation of these promising projects. Our commitment lies in offering career opportunities...

  • Quality Assurance Specialist

    2 days ago

    Conshohocken, Pennsylvania, United States Extremity Care Full time

    Job SummaryAt Extremity Care, we are seeking a highly detail-oriented and organized Quality Control Specialist to join our team. As a Quality Control Specialist, you will play a critical role in ensuring that all products meet established quality requirements.Key ResponsibilitiesConduct thorough inspections of HCT/P products in accordance with standard...

  • Quality Control Specialist

    3 months ago

    Conshohocken, United States Extremity Care Full time

    Job DescriptionJob DescriptionSalary: $55,000+Purpose:The Quality Control Specialist is responsible for ensuring that all products and quality control processes meet established quality requirements.Duties & Responsibilities: Inspect HCT/P products in accordance with standard operating procedures and regulatory requirements. Sort and segregate acceptable and...

  • Technical Quality Assurance Lead

    5 days ago

    Conshohocken, Pennsylvania, United States Syzygy Integration Full time

    Job DescriptionAbout Syzygy IntegrationSyzygy Integration is a technology company dedicated to delivering innovative solutions that address complex information awareness challenges for organizations in high-risk environments.Our MissionWe aim to lead the development of cutting-edge situational awareness tools, while ensuring secure and seamless communication...

  • Plan Document Specialist

    3 days ago

    Conshohocken, United States Top Stack Full time

    Job DescriptionJob DescriptionThe Plan Document Specialist updates, manages, and ensures the accuracy of medical plan documents, incorporating legislative changes and maintaining compliance while collaborating with internal teams and managing project deadlines.Responsibilities:Update and revise medical plan documents (SBC, SPD, BPD, SMM, SMR) to reflect...

  • Contamination Control

    2 months ago

    Conshohocken, United States PharmaLex Full time

    JOIN OUR CONSULTANT NETWORK! PharmaLex is a highly successful and growing consulting company for the Healthcare industry. Recently, we are receiving increase in demand for Contamination Control Auditors and our goal is to grow our consultant pool to prepare for these exciting and upcoming projects. We are committed in providing career opportunities in an...

  • Software Quality Assurance Specialist

    2 weeks ago

    Conshohocken, Pennsylvania, United States Syzygy Integration Full time

    Syzygy Integration is eager to enhance its workforce with talented professionals like youAt Syzygy Integration, an innovative technology firm, we are dedicated to delivering solutions that tackle the most pressing information awareness challenges faced by individuals in critical situations. Our mission is to spearhead the development of next-generation...

  • Contamination Control

    3 months ago

    Conshohocken, United States PharmaLex Full time

    Job DescriptionJob DescriptionJOIN OUR CONSULTANT NETWORK!PharmaLex is a highly successful and growing consulting company for the Healthcare industry. Recently, we are receiving increase in demand for Contamination Control Auditors and our goal is to grow our consultant pool to prepare for these exciting and upcoming projects. We are committed in providing...

  • Contamination Control Risk Management Specialist

    2 weeks ago

    Conshohocken, Pennsylvania, United States PharmaLex Full time

    Job OverviewPharmaLex is a prominent consulting firm dedicated to the Healthcare sector, currently experiencing a surge in demand for Contamination Control Experts. We aim to expand our network of consultants to meet the needs of upcoming projects. Our organization fosters a work environment that prioritizes trust, respect, collaboration, creativity,...

  • Contamination Control Risk Assessment

    3 months ago

    Conshohocken, United States PharmaLex Full time

    Job DescriptionJob DescriptionJOIN OUR CONSULTANT NETWORK!PharmaLex is a highly successful and growing consulting company for the Healthcare industry. Recently, we are receiving increase in demand for Contamination Control Consultants and our goal is to grow our consultant pool to prepare for these exciting and upcoming projects. We are committed in...

  • Contamination Control Risk Assessment

    3 months ago

    Conshohocken, United States PharmaLex Full time

    Job DescriptionJob DescriptionJOIN OUR CONSULTANT NETWORK!PharmaLex is a highly successful and growing consulting company for the Healthcare industry. Recently, we are receiving increase in demand for Contamination Control Consultants and our goal is to grow our consultant pool to prepare for these exciting and upcoming projects. We are committed in...

  • Lead Auditor for Internal Controls

    2 weeks ago

    Conshohocken, Pennsylvania, United States Cencora Full time

    Position OverviewAt Cencora, our commitment to fostering healthier futures is reflected in every role we offer. We are currently seeking a dedicated and meticulous professional to fill the position of Internal Audit Lead.This pivotal role involves assessing and enhancing our internal control frameworks, risk management strategies, and adherence to regulatory...

  • Senior Auditor for Internal Controls

    7 days ago

    Conshohocken, Pennsylvania, United States Cencora Full time

    At Cencora, our team members are fundamental to our mission of fostering healthier futures. We believe that every individual contributes significantly to our purpose. If you aspire to impact the health sector positively, we invite you to explore opportunities with our forward-thinking organization and help us enhance the well-being of both people and animals...

  • Lead Auditor for Internal Controls

    2 weeks ago

    Conshohocken, Pennsylvania, United States Cencora Full time

    About UsAt Cencora, our team members are central to our mission of fostering healthier futures. Every individual plays a vital role in achieving this purpose. Position OverviewWe are in search of a meticulous and experienced professional to fill the role of Internal Audit Lead. In this capacity, you will be instrumental in assessing and enhancing our...

  • Lead Auditor for Internal Controls

    2 weeks ago

    Conshohocken, Pennsylvania, United States Cencora Full time

    Position OverviewAt Cencora, our commitment to fostering healthier futures is paramount. We are looking for a dedicated and meticulous professional to fill the role of Internal Audit Lead. Key ResponsibilitiesAs the Internal Audit Lead, you will be instrumental in assessing and enhancing our internal control frameworks, risk management strategies, and...

  • Lead Auditor for Internal Controls

    2 weeks ago

    Conshohocken, Pennsylvania, United States Cencora Full time

    About CencoraAt Cencora, our team members are integral to our mission of fostering healthier futures. Every individual contributes significantly to our purpose.Position OverviewWe are looking for a meticulous and experienced professional to take on the role of Lead Internal Auditor. In this capacity, you will be essential in assessing and enhancing our...

  • Lead Auditor for Internal Controls

    2 weeks ago

    Conshohocken, Pennsylvania, United States Cencora Full time

    About CencoraAt Cencora, our team members are essential to our mission of fostering healthier futures. We are dedicated to enhancing the well-being of both people and animals globally.Position OverviewWe are in search of a meticulous and experienced professional to take on the role of Internal Audit Lead. In this pivotal position, you will be responsible for...

  • **Private Duty Nurse LPN

    2 days ago

    West Conshohocken, Pennsylvania, United States Quality Talent Group Full time

    Job Summary:We are seeking a compassionate and dedicated Licensed Practical Nurse (LPN) to join our team at Quality Talent Group. As an LPN, you will have the opportunity to make a profound impact on the lives of our patients and their families by providing high-quality clinical care in a home healthcare setting.Responsibilities:Perform patient assessments...

  • Clinical Quality Specialist

    2 weeks ago

    Conshohocken, Pennsylvania, United States Tandigm Health Full time

    Clinical Quality Specialist - Temporary (local remote) Tandigm Health, a pioneering organization in population health management, is seeking a Clinical Quality Specialist - Temporary. We are committed to fostering a diverse and inclusive workplace and offer a competitive compensation and benefits package. Key Responsibilities: OVERVIEW: As a Clinical Quality...