Associate Quality Assurance Associate Job Description

Associate Quality Assurance Associate Job Description

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Associate quality assurance associate provides interpretation and guidance for internal and external customers on non-clinical quality related regulations / guidelines (FDA, OECD, ICH, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current GLP standards;.

Associate Quality Assurance Associate Duties & Responsibilities

To write an effective associate quality assurance associate job description, begin by listing detailed duties, responsibilities and expectations. We have included associate quality assurance associate job description templates that you can modify and use.

Sample responsibilities for this position include:

Evaluates current laboratory practices
Perform designated test functions for operations
Collect, report, and analyze data for operations
Work with company WMS system for quality purposes
Performs Out-of-Box Audits as designated by sampling plan
Performs additional in-process testing as required
Supports QA department activities on a daily basis
Performs additional tasks as assigned with minimal supervision
Facilitating or supporting root cause analysis and corrective action identification through the use of quality problem solving tools
Prepares written records of all inspections and audits

Associate Quality Assurance Associate Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Associate Quality Assurance Associate

List any licenses or certifications required by the position: ASQ, IBWA, SQF, HACCP, ISO, API, 9000, QS, GS1, ACAMS

Education for Associate Quality Assurance Associate

Typically a job would require a certain level of education.

Employers hiring for the associate quality assurance associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Chemistry, Science, Education, Engineering, Technical, Biology, Manufacturing, Associates, Business, Computer Science

Skills for Associate Quality Assurance Associate

Desired skills for associate quality assurance associate include:

EPA
Excel
FDA
Internet
MS Word
OECD Good Laboratory Practice regulations and commonly used concepts
Outlook
Practices
Procedures within GLP QA field
SharePoint and PowerPoint

Desired experience for associate quality assurance associate includes:

Ability to identify areas/functions/tasks where additional controls can be implemented to maximize control efficiency
Ability to assimilate and interpret complex regulatory requirements
PhD degree in Chemistry/Biology, or relevant scientific/engineering discipline with 7-10 years of industry experience
Repeatedly moving about on foot to accomplish tasks, particularly for long distances or moving from one worksite to another
Occasionally pushing warehouse carts, using upper extremities to press against something with steady force
Good organizational skills with high level of attention to detail

Associate Quality Assurance Associate Examples

1

Associate Quality Assurance Associate Job Description

Job Description Example
Our innovative and growing company is hiring for an associate quality assurance associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for associate quality assurance associate
  • Administer the Document Control System and including documentation and tracking of requests, approvals and implementation
  • Maintain master documents and records (both hardcopy and electronic), audit files, raw data, reports, training records
  • Liaise internally with other functional departments
  • Able to prioritize and manage several projects and activities simultaneously
  • Perform critical control point checks, allergen checks on process as outlined in the HACCP requirements and other QA duties defined within the Quality Assurance Manual
  • Work with Technical team to test plans for automating test cases for product’s new / existing functionalities
  • Should be able to estimate the testing efforts from high level requirement
  • Execute test plans and report defects to development and business analysis teams
  • Configure / Execute test plans through Jenkins /Maven, Trouble shoot and report defects to development and business analysis teams
  • Keep project manager and integration manager up to date on test planning and execution status, defects and blocking issues
Qualifications for associate quality assurance associate
  • Knowledge of current regulatory requirements for pharmaceutical/medical devices industry
  • Knowledge in material sampling techniques and use of applicable ANSI/ASQ sampling standards
  • Effective skills on analytical thinking, problem solving, interpersonal relationships, written and oral communication, planning/organization, and meeting’s development and participation
  • Computer literate (MS Windows and MS Office)
  • Basic understanding of cGMP regulations in pharmaceutical or biotech manufacturing environment
  • Years experience in the Client Service processing departments or equivalent with another Broker/Dealer
2

Associate Quality Assurance Associate Job Description

Job Description Example
Our company is looking for an associate quality assurance associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate quality assurance associate
  • Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices
  • Performs various office-related duties
  • None
  • You will be involved in a variety of duties including inspections of laboratory/animal procedures and facilities, and audits of toxicology scientific reports to assure that the reports fully and accurately describe the data obtained during our studies
  • Performs established quality control procedures in the pre-production environment
  • Verifies output by performing pre-defined quality control steps ensuring quality, content, setup and data meet standards
  • Completes and signoff on all quality forms as required
  • Performs raw data checks on compliance mailing output
  • Performs checks to verify proxy card setup matches proxy statement
  • Performs checks to ensure APPs setup is correct
Qualifications for associate quality assurance associate
  • Minimum of 10 years progressive experience in pharmaceutical or biologics product complaint management and Quality IT systems roles
  • Expert working knowledge of development and implementation of IT systems for product complaint management
  • Detailed working knowledge of test standards and protocols
  • In depth knowledge of Statistical Tool to analyze effectiveness of Functional Test Data
  • Proficiency in Microsoft Office applications a must
  • ASQ CRE, CQM or CQE desirable
3

Associate Quality Assurance Associate Job Description

Job Description Example
Our growing company is looking to fill the role of associate quality assurance associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate quality assurance associate
  • Uses customer service expertise to assess existing practices and procedures for achieving and sustaining superior quality assurance
  • Drive best practices throughout our software development process that will improve overall software quality
  • Provide guidance in the creation of standard test environments, test plans and test scripts
  • The QA Associate is responsible for measuring employee performance by monitoring recorded customer interactions and to review employee email interactions with prospects by applying a standardized scoring system, as laid out in the QA Scoring and Coaching Program
  • Responsible for aggregating scoring results, conducting analysis and processing raw data into presentable format that provides critical insight into customer service performance
  • Assist with creating and coordinating a recognition program to celebrate great calls by reinforcing behaviors, and to correct poor call performance, in a way that encourages Representative participation and buy-in
  • Work as needed with QA Manager to develop coaching and training materials
  • Assists with development and ongoing refinement of QA Team activities
  • Development, enhancement and maintenance of an in-house automate test system
  • Writing code, designing and developing test suites and testing tools to test critical functionalities
Qualifications for associate quality assurance associate
  • Experience with Quality Assurance oversight and support for all phases of clinical trials and commercial API
  • Knowledge and experience with GMP, ICH Q7, and 21 CFR Part 11
  • Experience with Microsoft Office and other computer software such as Trackwise, MasterControl or other EDMS
  • Flexibility for changes in work priorities
  • Actively participates in company cultural programs including but not limited to safety, quality and accountability
  • Degree in Engineering (Industrial, Mechanical, Biomedical, ) or Quality
4

Associate Quality Assurance Associate Job Description

Job Description Example
Our growing company is looking for an associate quality assurance associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate quality assurance associate
  • Forward thinking, proactively seek out problematic processes and procedures and offer solutions new methods and resources to improve efficiency and increase quality
  • Work in partnership with WFN CPS and external CPS teams to expedite issues
  • Accurately Create Service Desk tickets and Rally Pls
  • Perform review and approval of documentation, deviations, CAPA in connection to batch disposition
  • Participate in execution of audits and inspections from competent authorities and external parties and act as subject matter expert
  • Maintain internal training level and keep up to date on cGMPs and regulatory requirements on global procedures, guidelines, policies, frames, and specifications
  • Meet established weekly and monthly department goals
  • Escalate material concerns
  • Continuously identify additional areas of process improvements in the QA/QC implementation
  • Automate test procedures where appropriate
Qualifications for associate quality assurance associate
  • Answers questions in response to complex customer issues that have been escalated for validation and resolution
  • Must be able to remain focused and deliverable-oriented while working independently
  • Proven experience interfacing with regulatory authorities and third parties
  • Hands on experience with technology transfer and change management
  • Creating and communicating a clear vision for TPM management
  • Excellent Leadership and communication skills with the ability to effectively promote and manage change
5

Associate Quality Assurance Associate Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of associate quality assurance associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate quality assurance associate
  • Communicating critical information accurately and timely in support of department goals
  • You will be involved in a variety of duties including
  • Responsible for oversight of the compliance program
  • Other tasks, as they arise
  • Ensure that laboratory documentation provided for product IND's for all products under development, comply with regulatory standards including in-house and CMO manufactured and tested IMPs
  • Ensure IMPs for clinical trials
  • Comply with cGMP
  • Participate in technical transfer of projects
  • Batch record review of IMPs
  • Provide support to projects as required
Qualifications for associate quality assurance associate
  • Automation expertise using tools like QTP/UFT/Selenium/Fitnesse/Cucumber
  • 5 years' experience with version control tools and processes (Subversion, CVS, Clear Case
  • Must have strong verbal, written and mathematical skills
  • Must be flexible in terms of working hours to meet the requirements of the position
  • Must be able to wear safety glasses/goggles and other personal protection as required for entry and work in the manufacturing facilities
  • Must have experience performing inspections and investigations

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