Associate, Assurance Job Description
Associate, Assurance Duties & Responsibilities
To write an effective associate, assurance job description, begin by listing detailed duties, responsibilities and expectations. We have included associate, assurance job description templates that you can modify and use.
Sample responsibilities for this position include:
Associate, Assurance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Associate, Assurance
List any licenses or certifications required by the position: CPA, ASQ, CRISC, CISA, CISM, CISSP, GS1, PKI, QAQC, QC
Education for Associate, Assurance
Typically a job would require a certain level of education.
Employers hiring for the associate, assurance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Accounting, Accountancy, Business, Education, Science, Information Systems, Technical, Chemistry, Engineering, Computer Science
Skills for Associate, Assurance
Desired skills for associate, assurance include:
Desired experience for associate, assurance includes:
Associate, Assurance Examples
Associate, Assurance Job Description
- Understand and recognize potential audit issues through analysis of relevant documentation
- Collaborate with team members in setting goals and assuming responsibilities
- Perform quality/process monitoring functions allowing Biologics to maintain a proactive quality program and to exceed customer expectations, industry and regulatory quality standards
- Identify quality assurance opportunities by leading/participating in internal and/or external audits
- Support the development and review of Standard Operating Procedures (SOP)
- Understand the capabilities of the Configuration Manager, including backup, restore
- Prepares and reviews batch release risk assessments
- Prepares and approves batch disposition documentation (eg
- Coordinates timely commercial and clinical product disposition of Cinryze to global markets and Legacy Baxalta intermediate products to further processing
- Maintain Shire required QMS databases
- Ability to lift 25lb+ related to tagging direct materials
- High School Diploma and 3+ years of related Scientific or Quality Assurance Experience, OR B.S
- Experience with pharmaceuticals is strongly preferred
- Excellent oral and written communication skills with the ability to interact at all levels both internally and externall
- Understand current accounting and tax theory
- Minimum 4 years of current or recent experience in public accounting
Associate, Assurance Job Description
- Review of QC test data for incoming bulk, raw materials and components, and release testing for products manufactured at the site
- In collaboration with Operations, work on long-term business needs for process improvements
- Handle recalls and communicate recalls to affected customers
- Communicate with suppliers on product quality complaints and closing out of these complaints
- Assist in obtaining documentation that will be submitted to regulatory bodies
- Assist with regulatory audits and inspections
- Perform quality control inspections for relabeling and kitting batches
- Ensure Standard Operating Procedures are adhered to by all TSMs in the Relabeling/Repackaging operation
- Ensuring that orders for gases of high quality, low tolerance are safely produced in a timely fashion commensurate with customer needs, ensuring that all products leaving the plant conform to internal Quality Control Manual requirements governmental and regulatory requirements
- Completion and filing of QC documentation and labeling of compressed gas cylinders
- Prepares, reviews, and analyzes reports
- Processes and submits paperwork, creates and maintains organized files, and identifies and resolves discrepancies in records or files
- Provide basic maintenance to equipment (e.g., cleaning, inspecting, changing labels and ribbons)
- 6 months experience with Walmart Logistics, including clerical related responsibilities (e.g., filing, data entry) using computer applications (e.g., email, spreadsheets, word processing) OR 1 year experience creating files, documents (e.g., emails, letters), spreadsheets, and datasets using computer applications (e.g., MS-Word, Excel)
- Requires a BS in a related scientific discipline with 1-3 years’ experience as a QA in a GLP regulated environment
- Higher pharmaceutical education - required
Associate, Assurance Job Description
- Works with development teams to insure test coverage for all functionality plus analyze and resolve defects
- Assesses readiness and deviation of model performance based upon test results and model specifications
- Assist in developing and managing client/vendor relationships
- Assist in manufacturing operations
- Assist leading cross-functional project teams
- Ability to troubleshoot manufacturing process deviations and analytical OOS results as needed
- Authors manufacturing investigations and change control documentation
- Ensures identification of true root cause
- Ability to supervise work and task completion of associates or interns
- Ability to work independently on complex problems and issues and determine acceptable solutions and approaches
- 2-3 years of operational experience in a Product Quality or certified
- Communicate with (or to) individuals or groups verbally and/or in writing
- 6 months experience performing Walmart Logistics clerical related responsibilities (for example, filing, data entry) using computer applications (for example, email, spreadsheet, word processing) including 6 months experience with 10-key data entry OR 1 year experience performing clerical related responsibilities (for example, filing, data entry) using computer applications (for example, email, spreadsheet, word processing) including 6 months experience with 10-key data entry
- 4 year degree in Life Sciences
- 5-10 years of Quality Assurance experience in the pharmaceutical industry
- Knowledge of sterile operations preferred.Knowledge of cGMPs and GLPs
Associate, Assurance Job Description
- Enhance and create automated test scripts and execute test plan and test cases
- Schedule, maintain, and perform field audits on all technicians
- Supervise the kick-off of large radiographic projects
- Reviews all requirements and assist in the creation a test strategy for a project
- Prepares test planning and test execution artifacts
- Writes test cases, executes the cases, and analyzes the test results
- Helps analyze multiple paths of testing utilizing a risked based approach
- Identifies any potential test automation candidates
- Provides input into high quality estimates at three different project phase levels
- Participates in test case peer reviews and resolves any action items
- BS Degree in natural sciences, engineering of pharmacy from an accredited college or university
- A minimum of 7 years experience in the pharmaceutical and or device industry
- Certified Lead Auditor (ASQ), highly preferred
- Experience with providing direct oversight and support to commercial manufacturing sites, including external and contract sites
- Comprehensive understanding of GMP including 21 CFR Part 4, 210/211
- Proficiency in MS Office applications and working knowledge of Trackwise
Associate, Assurance Job Description
- Ensure that R&D personnel maintain and administer the quality systems in compliance with the regulatory requirements
- Build and foster productive working relationships, including but not limited to OTS Operations colleagues across regions and attorneys
- Create, update and maintain Employee Training Plans
- Perform and/or review the daily, weekly, monthly, quarterly, and annual preventative maintenance on all applicable equipment
- Assist with vendor qualifications and complaint investigations
- Attend meetings held by QA/ Supply Chain Departments
- Communicates the requirements for batch release
- Performs document reviews for records for departments
- Completes and/or reviews documentation entries in the batch record
- Performs document tracking and routing
- Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations
- Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on a regular basis
- Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required
- Expert in Omni recordkeeping, ECI, Metrix, ODS
- The resource should be willing to work in challenging environments and ready to reskill and learn new technologies
- First-hand experience working in an agile development environment