Associate, Quality Control Job Description

Associate, Quality Control Job Description

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Associate, quality control provides guidance on GMP issues, interpretation of regulations and maintain awareness of regulatory trends and industry practices.

Associate, Quality Control Duties & Responsibilities

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

Sample responsibilities for this position include:

Maintains and updates QC LIMS
Performing thorough review of QC documents with respect to quality aspects
Reviewing CoAs and stability summary reports from contract testing laboratories against current specifications to ensure acceptability and compliance
Supporting with the preparation of Stability Data Reports
Entering and reviewing release and stability data into spreadsheet for trending analysis
Ensuring Quality Control documentation is properly processed through review and approval cycles
Processing documents in the electronic documentation system
Assisting with data archiving
Contributing to the success of the Quality Control team as needed
Providing support for administrative tasks

Associate, Quality Control Qualifications

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

Licensing or Certifications for Associate, Quality Control

List any licenses or certifications required by the position: KYC, CCRC, CCRP, CCRA, CDMP, CAMS, BCSI, SOP, ISO, IDOT

Education for Associate, Quality Control

Typically a job would require a certain level of education.

Employers hiring for the associate, quality control job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Science, Chemistry, Biology, Education, Life Sciences, Biochemistry, Biotechnology, Microbiology, Associates, Engineering

Skills for Associate, Quality Control

Desired skills for associate, quality control include:

Microsoft applications
Computer system validation
GMP and FDA
SUP and European regulations relating to material/product samples and testing
Compliance issues
Related regulatory/industry considerations
Scientific discovery
USP
LIMS
Basic principles

Desired experience for associate, quality control includes:

Handling Sample submissions to CLOs
Providing sample management
Assist in the resolution of comments from Quality Assurance
Review and comparison of clinical, non-clinical, pharmacovigilance and regulatory submission documents versus source documents for accuracy, content, formatting and compliance to local guidance's
Verify accuracy versus the statistical analysis plan and written document, being able to understand and interpret statistical data listings, tables and figures
Assist along with medical writing and statistics on resolutions of QA comments

Associate, Quality Control Examples

1

Associate, Quality Control Job Description

Job Description Example
Our company is hiring for an associate, quality control. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for associate, quality control
  • Report and participate in investigation of non-conformances in accordance with procedures
  • Complete assigned task following established procedures
  • Participate in Proficiency Testing and Continuing Education programs (CEUs) sponsored by in-house departments, regulatory agencies (FDA, AABB) and professional organizations
  • Perform complex (lab and/or field) experiments, and maintain detailed records of experiments and outcomes
  • Develop new protocols
  • Co-author publications
  • Document inspection results by completing reports
  • Maintain compliance with FDA/ISO regulations and standards
  • Test key attributes within the $500,000 & Under Risk Underwriting Level which includes Scored Assisted & Judgmentally Graded Business Credits
  • Establish procedures aligned with GMP laboratory control requirements
Qualifications for associate, quality control
  • Bachelors’ degree in Biology or Life Sciences required
  • Demonstrates ability to work effectively on problems of a diverse scope, with analysis/evaluation of data, using strong math skills
  • Demonstrates good facilitation, organizational and problem solving skills, demonstrated technical expertise
  • Ensures compliance with and performs all company business in accordance with Government (cGMP, FDA, DEA, OSHA, Safety) and Company Policies, Procedures, Goals and Objectives
  • Understanding and adherence to applicable Regulatory authority and guidances
  • Experience with HPLC, SDS-PAGE, cIEF, ELISA, Microbiology, pcr, RT-PCR (as applicable) for the analysis of pharmaceuticals
2

Associate, Quality Control Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of associate, quality control. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate, quality control
  • Familiarize and understand the ins and outs of the Flightpath system for efficient and accurate data entry and review of KYC information for businesses, individuals, and trust entities
  • Key person in performing production line audit per ISO 9001 2015 requirement & Assures compliance to in-house and/or external specifications and standards, such as EICC, ISO & Regulatory regulations
  • Responsible to develop/manage automated Quality Team tools
  • Manage Quality metrics reporting & assist Engineers to drive for improvement
  • Lead small team of EQM/BQM Inspectors towards high productivity & inspection effectiveness
  • Assists in trouble-shooting and determining root cause for quality issues & alert engineering and operations to conditions that may adversely impact the customer experience
  • Coordinate spare parts management to drive scrap improvement
  • Providing technical leadership and active oversight for sample processing and coordination for in-process, release, validation, stability and reference standard, including samples to and from internal and external contract sites
  • Reviewing and approving equipment validation protocol and reports, work orders, stability protocols, item specifications, and sample handling procedures
  • Ensuring effective and robust processes for sample documentation, filing, archival and retrieval
Qualifications for associate, quality control
  • Bachelors’ degree in Biology, Chemistry, or Life Sciences required
  • Demonstrates good knowledge of GMP regulations relating to material/product samples and testing
  • Skills & experience to manage targeted portfolios ( formal credit training, treasury product knowledge, problem loan experience)
  • Bachelor’s degree and at least 6 years of quality control or product manufacturing experience
  • Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories
  • Drive for results, Proactive and self driven
3

Associate, Quality Control Job Description

Job Description Example
Our growing company is looking to fill the role of associate, quality control. 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 control
  • Author reports for environmental excursions
  • Read, trend and report environmental, personnel, in-process, raw material, finished product and water testing results
  • Support Stability Programme on site and frequent collaboration with global Stability Product Representatives (SPR) or Product Quality Leads (PQL) regarding all stability programme matters
  • With a high degree of technical flexibility, work across diverse areas within QC
  • Write protocols and perform validation and equipment qualification/ verification
  • Introduce new techniques/ Processes to the area, where appropriate
  • May provide technical guidance.May contribute to regulatory filings
  • Responsible for assisting with laboratory analysis for clinical release and routine stability testing
  • Initiates non-conformances and participates in investigations when required
  • Perform routine control and calibration of DQC instruments and equipment and ensures that laboratory areas are clean and maintained in a compliant manner
Qualifications for associate, quality control
  • Knowledge in computer hardware/software/operating system/network
  • Must possessed strong knowledge in Visual Basic Programming & Microsoft Excel/Access
  • Knowledge in Microsoft InfoPath & SharePoint will be an added advantage
  • Minimum 1 year of relevant experience or equivalent combination of education and work experience
  • Experience of assembly processes, procedures, test process, software download and set up will also be an added advantage
  • Familiar with ISO9001 requirement
4

Associate, Quality Control Job Description

Job Description Example
Our innovative and growing company is looking for an associate, quality control. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for associate, quality control
  • Plan and perform analyses with great efficiency and accuracy
  • May conduct lab investigations as necessary
  • QC Sample receipt and GMP documentation of sample moves
  • Routinely and within specified time requirements aliquot all release Drug Substances for QC testing
  • Sample Management for Stability and Reference Standard Programs
  • File deviations, support investigations and implement CAPAs as necessary
  • Track test data and generate In-Process Result Summary Reports as defined by appropriate procedures
  • Respond to equipment alarms as necessary
  • Analyze data and prepare and maintain clear and precise documents according to company policies and ISO requirements
  • Ensures corporate compliance to Regulatory Agency requirements
Qualifications for associate, quality control
  • Demonstrated Scientific “problem solving” skills
  • Strong Molecular Biology Applications background
  • Positive external and internal relationship management skills
  • Proven ability to thrive in change oriented environment
  • PhD, MS or BS in Chemistry, Pharmaceutical Sciences, Life Sciences or equivalent
  • PhD+ 10 years or MS/BS +15 years of relevant experience in QC or equivalent experience in commercial pharmaceutical industry
5

Associate, Quality Control Job Description

Job Description Example
Our company is growing rapidly and is hiring for an associate, quality control. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for associate, quality control
  • Perform stability tasks with LIMS and in accordance with stability reports
  • Monitor QC queues for incoming forms
  • Accurately review customer information and form level data
  • Accurately track errors and changes to form level data
  • Cross train for special processes as required
  • Subject matter expert in regards to Raw Material testing and equipment used for both Chemistry and Microbiology testing of the raw materials
  • Approves finished product by confirming specifications
  • Processing and maintenance surrounding special loan products as needed
  • Performs, as assigned, in-process and final product testing of Dendreon products
  • Initiating instrument maintenance records, decommissioning protocols, other equipment related protocols, RAR reports, change control, AIV validation protocols & report, as applicable
Qualifications for associate, quality control
  • Willing to be certified on equipment, as required by location
  • Experience with Quality Control testing and laboratory operations for common microbiological testing methods and equipment
  • Responsibilities will include data analysis and communication of results, writing protocols and performing assay transfer/validation and equipment qualification/verification maintaining and operating specialized equipment
  • BA/BS in Biology or equivalent science degree
  • Knowledge of general laboratory safety
  • BA/BS degree in a related scientific discipline or some related college coursework with a minimum of 2 years experience in a biotech lab environment

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