QC Associate (Raw Materials) Job at Amaris Consulting

QC Associate, Data Digitalization

10x Genomics is seeking a detail-oriented individual to join our Quality Control...

Location

United States , Pleasanton

Salary:

31.00 - 43.00 USD / Hour

10x Genomics

Expiration Date

Until further notice

Requirements

B.S. or M.S. in Biological Engineering, Bioinformatics, Data Science, or a related Life Science discipline
1 year of experience in a manufacturing or QC environment (NGS or PCR experience preferred)
Python essential for building Streamlit apps, managing Claude/AI API integrations

Job Responsibility

Follow ISO standard to conduct QC testing on raw materials, intermediates, and finished products using metrology check, PCR, NGS, and HPLC
Use Python and AI tools (Claude) to help write and maintain scripts that streamline QC inspections, data collection, and analysis
Initiate and follow up on nonconformance, support new product launches and investigations
Work with the team to identify metrics, and help build and maintain real-time data visualizations using Streamlit and Retool

What we offer

Health Package
Easy-to-use Benefits
Family oriented
Generous Time Off
Award-Winning Workplace

Fulltime

Supervisor, QA Raw Materials

The Supervisor, QA Raw Materials is responsible for leading a team of QA Raw Mat...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in relevant scientific discipline with a minimum of 5+ years’ experience in related GMP industry working in Quality Assurance or Quality Control groups which support receipt, inspection, or release of materials
Equivalent combination of education and experience considered
Knowledge of USP and EP pharmacopoeias, and pharmaceutical raw material compendial testing
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as EU, ICH
Ability to apply basic scientific principles to solve operational and quality tasks
Experience with RCA, technical writing, and working with quality related investigations

Job Responsibility

Perform review of external documentation and internal GMP documentation associated with incoming raw materials, components, chemicals, excipients, and Active Pharmaceutical Ingredients (API)
Provide Quality Assurance oversight to Materials Management and Quality Control, ensuring that site SOP’s and raw material specifications are adhered to
Responsible for the review and analysis of test results
ability to interpret and comprehend scientific information and data related to QC Micro and QC Analytical testing
Initiation, review, and disposition or closure of raw material quality systems
Assist in the identification, isolation, and containment of potentially nonconforming materials
Assist in the identification and management of expired material
perform scrapping of materials with Materials Management
Assist Materials Management and Project Management with finished product shipments
Provide input, review, and approval of new and revised raw material specifications

Fulltime

Sr. QC Associate I

10x Genomics is looking for a Sr. QC Associate I to join our Quality Control tea...

Location

United States , Pleasanton

Salary:

37.64 - 50.91 USD / Hour

10x Genomics

Expiration Date

Until further notice

Requirements

B.S. in Analytical Chemistry, Biochemistry, or a related field
5+ years of laboratory experience specifically in a QC environment
Strong hands-on experience with NGS and tissue-based assays (including immunofluorescence and flow cytometry)
Proficiency in PCR, qPCR, spectrophotometry, spectrofluorometry, and HPLC
Experience collaborating with R&D and QA on risk-based QC strategy assessment including assay robustness, assay cost, and alignment of QC checkpoints to the manufacturing process
A solid understanding of New Product Introduction (NPI) and manufacturing processes
Ability to manage and track diversified QC assays and projects in a rapidly evolving environment
Strong critical thinking, logical problem-solving skills, and the ability to communicate effectively with stakeholders

Job Responsibility

Execute QC Testing: Perform quality control operations according to defined procedures to ensure the integrity and quality of raw materials, intermediates, and finished goods
Data Analysis & Disposition: Complete QC testing in a timely manner and disposition materials based on established acceptance criteria
Product Development and Sustaining Support: Serve as the primary QC point of contact to oversee project completion, providing expert guidance on assay setup and assisting in the introduction and optimization of new products and processes
Assay Cross-Training: Cross-train on various inspections, including first article inspection, metrology, microscopy, analytical assays, and NGS
Documentation: Maintain quality control batch records and ensure Good Documentation Practices (GDP) under ISO requirements. Accurately track QC test data, calibration records, and inventory. Draft Work Instructions in collaboration with the Manufacturing Systems & Engineering team
Quality Compliance: Initiate non-conformance, deviation reports, engineering change orders (ECO) and follow up on necessary action items. Ensure that lab operations and workflow execution are compliant with ISO requirements
Problem Solving: Effectively identify and communicate complications arising from QC testing with minimal supervision. Work closely with scientists to establish and maintain technical solutions. Drive completion of investigations and minimize disruptions to QC operations

What we offer

Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Generous time off
Competitive and comprehensive health benefits package
Family friendly policies like parental leave

Fulltime

QC Associate II

As a QC Associate II, you will be responsible for inspecting raw materials, inte...

Location

United States , Pleasanton

Salary:

31.78 - 43.03 USD / Hour

10x Genomics

Expiration Date

Until further notice

Requirements

B.S. in Biological Engineering, Molecular Biology, Analytical Chemistry, Chemical Engineering, or related discipline
3 years of relevant laboratory experience in manufacturing and QC of life science products (e.g., PCR, NGS, protein analysis, HPLC)
Willingness to rotate through various laboratory and administrative tasks and ability to prioritize workload, and adhere to deadlines
Proficiency in data entry using tools such as Excel, Oracle ERP and LIMS
Demonstrated ability to work both independently and as part of a team
Strong attention to detail, organization, and commitment to quality
Effective communication and observational skills
Excellent critical and logical thinking skills to analyze and troubleshoot issues

Job Responsibility

Conduct quality control testing on raw materials, intermediates, and finished products according to established procedures
Perform molecular biology techniques, including PCR, next-generation sequencing, microscopy, cell and tissue based assays, and HPLC
Participate in instrument QC workflows, including training to work with mechanical stages and read technical drawings and first article inspection report
Accurately follow work instructions and standard operating procedures, while proactively identifying and reporting discrepancies
Maintain comprehensive and accurate records, including QC batch files and Receiving Inspection Reports, in accordance with Good Documentation Practices
Efficiently communicate complications identified during QC testing and collaborate with engineers and scientists to resolve issues
Initiate non-conformance, deviation reports, engineering change orders (ECO) and follow up on necessary action items. Ensure that lab operations and workflow execution are compliant with ISO requirements. Drive completion of investigations and minimize disruptions to QC operations
Assist in root cause investigations for non-conforming lots and contribute to continual improvement efforts
Support process and product development activities, including process optimization, guard band and stability studies, and gauge R&R

What we offer

Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Health Package
Easy-to-use Benefits
Family oriented policies like parental leave
Generous Time Off

Fulltime

Associate Director, QC Manufacturing Support

We are seeking an Associate Director, QC Manufacturing Support to provide GMP ra...

Location

United States

Salary:

160000.00 - 180000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BS or advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, etc.)
10+ years of biotech industry experience in QC operations or analytical support roles
At least 6 years demonstrated experience supporting a GMP raw materials testing program
Understanding of analytical techniques relevant to monoclonal antibody testing
Experience in relationship management with external analytical test sites
Ability to effectively prioritize and manage multiple projects
Understanding of quality systems, cGMP regulations, and industry standards applicable to biopharmaceutical manufacturing and testing
Excellent communication skills
able to collaborate effectively across multidisciplinary teams
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Job Responsibility

Author internal raw materials testing specifications, specifically for non-compendial raw materials
Assess test methods being used by CDMOs for non-compendial raw materials to ensure they meet industry expectations for method verification and/or validation
Perform change control activities to ensure internal raw material specifications are updated and communicated to impacted test sites
Review and assess impact of vendor change notifications related to GMP raw materials
partner with internal and external stakeholders to development plans for material changes with major impact
Provide general analytical support to DS, DP, and MSAT teams in conjunction with QC Analytical Sciences on coordination and execution of in-process analytical testing
may include review of manufacturing-related sampling/testing plans, supporting materials and process-related risk assessments, (e.g., extractables/leachables, nitrosamines, etc.), sample shipment coordination, and analytical data review and management
Interface with internal and external stakeholders to support manufacturing campaigns at CDMOs, including supporting requests for information, document review, and audits/regulatory inspections as required
Support deviations, OOS/OOT/OOE investigations, and CAPAs related to GMP raw materials and in-process testing

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

New

Manager Quality Control (Micro and Sample Management)

Manager Quality Control (Micro and Sample Management) at Amgen Singapore Manufac...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master's degree and 2 years of Quality or Operations related experience
OR Bachelor's degree and 4 years of Quality or Operations related experience
OR Diploma and 8 years of directly related experience
Strong knowledge and understanding of microbiology testing methodology and strategy for contamination control
Knowledge and experience with general GMP laboratory operations, data integrity requirements and associated laboratory equipment
Experience with computerized laboratory information management systems, electronic laboratory notebooks and other QC analytical equipment
Ability to lead diverse teams
Good communication skills (technical writing and verbal communication/presentation)
Ability to work in cross-functional and multisite teams

Job Responsibility

Lead and supervise QC Microbiology Shift teams
Maintain the weekly lab schedule and prioritize daily work tasks
Provide Quality oversight to ensure processes follow cGMP
Ensure facilities, equipment, materials, organization, processes, procedures and products align with cGMP
Perform review, approval and tracking of cGMP processes, procedures, documents and records including nonconformance records and CAPAs
Oversee day to day activities in microbiology (routine environmental & utilities monitoring
raw material and product testing such as bioburden, microbial limits test, endotoxin, qPCR, microbial ID
media, reagent and culture qualification such as growth promotion
etc.)
Oversee sample management and stability (sample logging, receipt and processing, sample aliquoting, movement and storage of samples, stability initiations and time point pulls, etc.)

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Qc Laboratory Technician

A manufacturing organization is seeking a Quality Control Laboratory Technician ...

Location

United States , Cincinnati

Salary:

41600.00 - 41700.00 USD / Year

Beacon Hill

Expiration Date

Until further notice

Requirements

Associate’s or Bachelor’s degree in a scientific discipline (chemistry, biology, or related field preferred)
Prior experience in a quality control or laboratory setting within a manufacturing environment is preferred
Familiarity with basic laboratory techniques and analytical testing methods
Experience working with laboratory documentation and controlled procedures
Strong attention to detail and ability to follow written instructions
Good communication skills and ability to work effectively in a team environment
Comfortable working in a regulated or compliance-driven setting

Job Responsibility

Perform routine quality control testing on raw materials, in-process samples, and finished products using established methods
Accurately document test results and maintain complete laboratory records in accordance with internal procedures
Prepare samples, reagents, standards, and laboratory solutions as required
Operate, maintain, and calibrate laboratory instruments and equipment
Identify, document, and communicate out-of-specification or nonconforming results to appropriate personnel
Support investigations related to quality issues, deviations, or process improvements
Maintain a clean, organized, and compliant laboratory environment
Follow all safety procedures, quality guidelines, and standard operating procedures
Collaborate with manufacturing and quality teams to support production activities as needed
Perform other laboratory or quality-related duties as assigned

Fulltime

Associate Quality Control (Microbiology)

Amgen is one of the world’s leading independent biotechnology companies. For ove...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Microbiology, Biological Sciences, Life Sciences or related technological field and 2 years of directly related experience
Associate’s Degree in Microbiology, Biological Sciences, Life Sciences or related technological field and 4 years of directly related experience
Diploma in Microbiology, Biological Sciences, Life Sciences or related technological field / GED and 6 years of directly related experience
At least 1-3 years of relevant professional work experience within the biopharmaceutical industry and QC laboratory experience preferred
Possess sound knowledge and understanding of GMP pharmaceutical operations and associated QC testing methods, inclusive of GMP laboratory operation
Experience with Quality Control testing and laboratory operations for common microbial testing methods and equipment (e.g. including but not limited to bioburden, endotoxin, microbial identification, environmental monitoring, microbial limits, growth promotion, biological indicators)
Able to interact effectively with variety of communication and working styles and ability to work well in teams
Ability to manage multiple simultaneous activities in a rapidly changing environment
Possess problem solving skills with the ability to apply logic and assess data to troubleshoot and reach decisions or solutions related to assay
Your selection for this role will be subject to fulfilling the medical requirements of this job scope

Job Responsibility

Execute testing and/or review for routine environmental, water, raw material and product testing (e.g. bioburden, endotoxin, qPCR, microbial ID etc.)
media, reagent and culture qualification (e.g. growth promotion, DNA positive controls, microorganisms culture types etc.)
Sample management such as sample logging, movement, storage of samples, reconciliation of sample receipt, aliquoting samples, management of stability samples, and sample shipment to Amgen network sites and/or contract labs
Involvement in document revisions and report writing
Involvement in method transfers, method validation/verification and sample type qualification
Laboratory housekeeping and document archival
Project management / Involvement in QC projects (e.g. Continuous Improvement/ Operational Excellence)
When required, able to support 12-hour rotating day shift (8am - 8pm), inclusive of weekends and public holidays

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

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QC Associate (Raw Materials)

Job Description

Job Responsibility

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