Quality / Control Associate Job Description
Quality / Control Associate Duties & Responsibilities
To write an effective quality / control associate job description, begin by listing detailed duties, responsibilities and expectations. We have included quality / control associate job description templates that you can modify and use.
Sample responsibilities for this position include:
Quality / Control Associate Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality / Control Associate
List any licenses or certifications required by the position: KYC, CCRC, CCRP, CCRA, CDMP, CAMS, BCSI, SOP, ISO, IDOT
Education for Quality / Control Associate
Typically a job would require a certain level of education.
Employers hiring for the quality / control associate 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 Quality / Control Associate
Desired skills for quality / control associate include:
Desired experience for quality / control associate includes:
Quality / Control Associate Examples
Quality / Control Associate Job Description
- Author test methods, SOPs, work instructions for QC test methods and operation of QC work processes and systems
- Lead the generation of method qualification protocols in collaboration with Process Development
- Track QC projects and ensure progress is aligned with established timelines
- Lead QC investigations and provide solutions to issues including OOS, deviations or CAPA
- Review electronic data tables and/or data within a LIM System for accuracy, consistency, and compliance with SOPs and BPs
- Review reagent preparation documentation for accuracy, completeness, and compliance with SOPs
- Coordinates preventive maintenance activities for applicable equipment with outside vendors
- Provides technical expertise and testing support to other departments as part of cross-functional project teams
- Performs various mathematical calculations including subtraction, addition, multiplication, division, and statistical analysis including means, standard deviations, coefficient of variation (% std dev)
- Ensure new accounts, when applicable, are linked properly to an existing Signature Card within timely manner to avoid imaging rejects
- Demonstrates good knowledge of computer system validation, GMP and FDA, SUP and European regulations relating to material/product samples and testing
- Edit and review Standard Operating Procedures (SOPs)
- Ability to maintain lab equipment including qualification and calibration
- Technical understanding and working knowledge of contemporary molecular biology , cell biology, microbiology and/or biochemistry • Ability to operate within a clean room environment as needed
- Technical understanding and working knowledge of contemporary molecular biology , cell biology, microbiology and/or biochemistry
- Degree in related science area OR 4 years industry experience
Quality / Control Associate Job Description
- Perform general QC practices and suggest solutions
- Evaluate lab practices for compliance on a continuous basis
- Manage the transfer and validation of analytical methods from Analytical Development to QC the transfer and validation of methods to OTL or other sites
- Responsible for OOS, lab and protocol deviations, Implement corrective action plans when necessary
- Review of records, generation of CoAs for product release
- Responsible for QC’s training
- Review PVR protocols and reports, raw data, in support of viral clearance studies
- Manage and prioritize testing and operations of QC Micro team
- Design and oversee qualification of new microbiological techniques and equipment
- Perform continuous improvement pertaining to water testing, lab microbiology techniques, and environmental monitoring initiatives
- Clear understanding of Quality Control equipment validation and maintenance, data integrity requirements
- BS in a related science (e.g., Chemistry, Biochemistry) with minimum 5 years
- Sound understanding of business controls
- Stand unassisted for 6-8 hours per day
- The successful candidate will be someone who can demonstrate the ability to coordinate multiple priorities, successfully resolve complex matters, quickly understand processes/workflows, identify risks, and effectively tailor their communication (written/verbal) to their audience They must be able to identify opportunities for process enhancements while supporting existing standards with a focus towards providing excellent service to our clients
- Handling of physical account documentation may require lifting up to 10 pounds
Quality / Control Associate Job Description
- Maintains knowledge of key Samaritan’s Purse data entry procedures to ensure accurate clean-up of donor accounts
- Corrects identified errors on our donor accounts, including, but not limited to, addresses, spelling, and salutations
- Assesses accounts that have been identified as potential duplicates, following data entry procedures to determine whether they can be merged, and merges accounts if appropriate
- Uses various Internet search tools to verify donor information
- Maintains a clean and neat working environment at all times
- Assist in implementing quality control standards, methods and procedures
- Monitor and track common deviations and problem documentation, and investigate to determine root causes
- Assist in recommending form and SOP modifications, and changes to standard protocol wording to avoid deviations
- Assist in maintaining and revising QC documents, processes, manuals, and reports
- Assist in updating QC guidance documents
- M.S./M.A
- Diploma in Information Technology / Equivalent
- High Certificate with Minimum 1-2 year relevant experience
- Capable of executing work with minimum supervision
- PhD molecular biologist or biochemist preferred with 5-7 years of Quality Control experience or MS with 10 – 12 years of Quality Control experience
- Candidate should be well versed and experienced in bioanalytical methods and experience in managing a Quality Control laboratory under GMP compliance
Quality / Control Associate Job Description
- Leads, develops implements and maintains quality strategies, procedures and systems in line with corporate business goals
- QC Raw Material Group
- QC Semi-Finished/Finished Product Group
- Manager of QC Annual Stability Group
- QC-IT Support
- QC Metrology
- Review mortgage loan documents and input of findings into numerous software systems
- Data and loan research, document verification and exception report resolution as directed
- Responsible for compiling information into, and extracting information from, spreadsheets and Access database forms in order to complete research and project assignments
- Project work as assigned by Quality Control leadership
- Travel to other local CS office locations as required (overnight travel is <10%)
- Familiarity with validation and technology transfer to internal and external analytical labs of both partners and CMOs/CROs
- 4+ years of managerial experience, prefer more than 5 years in non-academic industry experience and/or equivalent combination of education and experience
- Bachelor's degree from four year College or university in life science discipline
- Excellent knowledge of GMP, ICH, USP and global compendial regulations and guidance
- Proven industry expertise in pharmaceutical microbiology is required
Quality / Control Associate Job Description
- Participates in core functions of team related to equipment & instrument projects
- Coordinates QC lab support projects related to instrumentation & equipment with other departments
- Ability to flex and respond to unexpected situations/demands
- Receive and distribute incoming supplies
- Perform GMP lot release and in-process testing for microbiology based methods such as growth promotion, gram stain, rapid sterility, and endotoxin
- Perform Growth Promotion and Qualification of Challenge Organisms
- Perform Water Sampling and Testing
- Perform Gas Sampling (Viable and Non-Viable)
- Perform environmental monitoring activities such as collecting viable air and surface EM samples, collecting non-viable particulate samples, reading of plates and trending for EM data
- Perform routine lab cleanings, inventory checks, and material ordering
- Self-starter, Goal Oriented, an takes initiative
- Must feel comfortable reporting errors to department Supervisor
- Proficient in WMS, PMMS
- Some experience in an industrial or research laboratory preferred
- BS in a Biological Science-related field
- Previous experience in QC testing and reporting