Manager Quality Control - HPLC Labs Job at Amgen (Juncos)

Manager Quality Control - Biochemistry Labs

Lead all Biochemistry laboratories during the night shift (including Wet Chemist...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Or Master’s degree and 3 years of Manufacturing Support, Quality Control and/or Laboratory experience
Or Bachelor’s degree and 5 years of Manufacturing Support, Quality Control and/or Laboratory experience
Or Associate’s degree and 10 years of Manufacturing Support, Quality Control and/or Laboratory experience
Or High school diploma / GED and 12 years of Manufacturing Support, Quality Control and/or Laboratory experience
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead and develop a successful QC team, fostering a culture of safety, compliance, and continuous improvement
Oversee daily QC operations to ensure timely, accurate, and reliable testing aligned with production schedules
Serve as the QC subject matter expert during audits and inspections, ensuring inspection readiness
Provide technical guidance and troubleshooting support for complex assays and testing issues
Drive training initiatives and ensure team members are appropriately cross-trained for operational flexibility
Monitor assay results and documentation to ensure compliance with cGMP, SOPs, and regulatory standards
Communicate clear expectations on safety, quality, and compliance, addressing discrepancies promptly
Organize and prioritize team tasks based on impact and deadlines, adjusting as needed to meet changing requirements
Use data and dashboards to monitor QC performance metrics, identify trends, and implement improvements
Collaborate with cross-functional stakeholders to align QC activities with broader site and organizational goals

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and an annual site shutdown

Fulltime

Chemistry Technician I/II

The Quality Control Technician supports the Quality Control department by assist...

Location

United States , Wichita

Salary:

Not provided

Fagron

Expiration Date

Until further notice

Requirements

A bachelor’s degree in a science field and 0-2 years in pharmaceutical quality control or combination of QC and other pharmaceutical quality experience. (graduate school may be considered toward) experience)
Previous experience in a pharmaceutical quality control position adhering to cGMP guidelines preferred.
Clear and effective communication Skills.
Ability to concentrate for extended periods of time and follow established safety and procedures.
Computer experience using Microsoft Office.

Job Responsibility

Collect and prepare samples for chemical analysis as required
HPLC testing, UV-vis testing, TOC testing, pH testing, conductivity testing, water content Karl Fischer volumetric and coulometric
Participate in method development
Help manage sample tracking
Help maintain lab organization
Lab Waste management
Adhere to procedural and regulatory guidelines for controlled substances
Assist in the quality process, and ensure the integrity of product quality, manufacturing, certification and release activities.
Adhere to the company safety regulations and assist in the training and awareness of safety guidelines to new employees in the department.
Maintain a clean, orderly and safe work environment.

What we offer

Competitive salary
Comprehensive benefits
Performance package
Ability to be part of an international leader in an expanding industry.

Fulltime

Senior Associate Quality Control I (Chemistry)

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

Location

Singapore , Tuas

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in Chemistry, Biochemistry or related technological field
Bachelor’s degree in Chemistry, Biochemistry or related technological field and 2 years of directly related experience
Associate’s degree in Chemistry, Biochemistry or related technological field and/or 4 years of directly related experience
High school diploma in Chemistry, Biochemistry or related technological field / GED and 6 years of directly related experience
Preferred 4 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry and laboratory testing experience preferred
Strong knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods
Strong technical knowledge in and experience with the following QC Chemistry/ Biochemistry/ Raw material testing methods and equipment is required: Immunosorbent Assay/Cell based Bioassay: Potency, Host Cell Proteins, ELISA
Chromatography: UPLC, HPLC, LC-MS, GC-HS
General Chemistry: Capillary Electrophosis, LOD, Autotitration, KF, Optical Rotation, FT-IR, Conductivity, TOC, pH, wet chemistry
Ability to preempt issues and disruptions to lab operations and develop mitigation actions

Job Responsibility

Plan, schedule, perform analytical testing and approval of test results on raw materials, water, in-process control, drug substance and stability samples in GMP pharmaceutical environment
Troubleshooting issues related to analytical testing, techniques and equipment
Conduct laboratory investigations and assist in timely closure of investigations, CAPAs and deviations
Support method verification and method validation/transfer for new product introduction (when required)
Train new/ junior laboratory staff and ensure all staff are appropriately trained and qualified to execute the duties assigned to them with respect to the job
Support laboratory operations including but not limited to equipment qualification, calibration and maintenance, reagent/buffer preparation, chemicals/consumables inventory, laboratory housekeeping and document archival duties
Perform periodic review of laboratory procedures and risk assessment
Author of SOPs/protocols/reports
Support regulatory inspections
Participate in continuous improvement initiatives and projects

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

New

Associate Quality Control (Analytical)

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 Chemistry, Biochemistry, Life Science or related technological field and 2 years of directly related experience OR Associate's Degree in Chemistry, Biochemistry, Life Science or related technological field and 4 years of directly related experience OR High School Diploma in Chemistry, Biochemistry, Life Science or related technological field / GED and 6 years of directly related experience
1-2 years of relevant laboratory experience in the commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred
Knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods
Experience with Quality Control testing and laboratory operations for common testing methods and equipment (e.g. including but not limited to UPLC, HPLC, LC-MS, GC-HS, LOD, Auto-titration, KF, Optical Rotation, wet chemistry, FT-IR, pH, conductivity, TOC, Potency, ELISA, Capillary Electrophoresis, DNA Testing)
Good communication skills (technical writing and verbal communication/ presentation)
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
Problem solving skills and troubleshooting skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.

Job Responsibility

Perform analytical testing of in-process control, drug substance intermediate, final release, stability and plant cleaning samples in a GMP pharmaceutical environment
Support laboratory operations including but not limited to equipment qualification, calibration, cleaning and maintenance, reagent/ buffer preparation
Responsible for maintenance of chemicals and consumables inventory
Ensure proper handling, storage, disposal of all chemicals used in the lab
Responsible for laboratory housekeeping and document archival duties
Participate in laboratory investigations and assist in timely closure of investigations, CAPAs and deviations
Participate in method verification and method validation/ transfer for new product introduction (when required)
Perform review of laboratory data/ records
Assist in SOP/ protocol/ report writing
Assist in periodic review of laboratory procedures and risk assessment

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Technician - Quality Assurance

The Technician - Quality Assurance will be responsible for testing our finished ...

Location

United States , Montgomery

Salary:

Not provided

Coca-Cola Bottling UNITED

Expiration Date

Until further notice

Requirements

Minimum age 18 years old
Personal Protective Equipment (PPE) as required by position and compliance with UNITED safety policies
Regular and prompt attendance is an essential function of the job
Ability to read, write and speak English
Ability to maintain a neat professional appearance within Company guidelines
Ability to maintain safety and security of Company assets
Ability to utilize all Company provided resources and technology
High school diploma or general education degree (GED)
or 6+ months related experience and/or training
or equivalent combination of education and experience

Job Responsibility

Perform beverage attribute testing to include: Brix, Assay, CO2, Net Contents, pH and Taste & Odor
Perform package attribute testing to include: Closure Removal Torques, Can Lid Application (Where Applicable), and Visual Appearance
Perform finished product attributes such as: Correct Bottle/Can, Correct Closure/Lid, Correct Label, Correct Production Date Code to include final packaging (Cases, Cartons, Trays, Wraps, etc.) and verification of any Promotional Identification
Perform Micro sample collection and testing
Perform Syrup testing such as Brix, Assay, pH to include the use of an ultra-performance liquid chromatography (UPLC) or a high-performance liquid chromatography (HPLC) unit
Perform lab equipment calibrations and/or verifications as needed. Lab equipment maintenance and problem troubleshoot is required as needed
Perform water treatment duties as described by the Quality Manager where applicable
Perform Internal Clean in Place (CIP) setup as described by the Quality Manager where applicable
Participate in the Sensory Program where applicable
Data entry from product testing is required in Laboratory Data Management System (LDMS) to include review of test results and reaction should an out of specification situation arise. Knowledge of the Product Hold program (when to use and when not to use) is a must. Assist in writing standard operating procedures (SOP’s) as needed to include the use of Master Control

What we offer

Two weeks paid vacation within first year
Comprehensive Medical Preferred Provider Plan
Dental, vision, flex spending
Employee Assistance Program
Company paid life insurance ($50,000)
Additional optional insurance (accident, critical illness, universal life, home & auto)
Paid maternity & paternity leave
Paid holiday & sick time
401(k) match (50% on first 6%
plus an additional annual match of up to 3%)

Fulltime

New

Chemistry Supervisor

The Chemistry Supervisor is responsible for overseeing the operations of the che...

Location

United States , Wichita

Salary:

Not provided

Fagron

Expiration Date

Until further notice

Requirements

Bachelor's degree or equivalent in chemistry or related scientific field, graduate degree is a plus
Working knowledge of Current Good Manufacturing Practices and appropriate sections of CFR 210 and 211
Six (6)+ years of experience in an analytical chemistry laboratory, combined laboratory and pharmaceutical quality experience will be considered (graduate degree may be considered as contribution to experience)
Previous management experience preferred
Knowledge of cGMP/GLP/GDP, USP, FDA regulatory requirements
Excellent interpersonal communication and organizational skills
Demonstrated leadership skills
Qualified to work with controlled substances
Experience Handling Biohazardous materials
Ability to manage multiple direct reports and provide performance feedback

Job Responsibility

Management of lab staff including completion of performance feedback, reviews, disciplinary action and timecard administration
Ensure testing is initiated and performed in a timely manner and adhering to quality standards
Act as laboratory SME
Draft protocols and coordinate with laboratory manager to conduct investigations and special studies as needed
Draft and edit SOPs as needed
Approve CoAs as needed
Conduct and/or approve method validations as needed
Review of paperwork for compliance
Draft reports and communicate results
Perform analytical chemistry work including but not limited to: HPLC/UPLC, Infrared spectroscopy, UV/Vis spectroscopy, pH, Titrations, Karl Fisher (volumetric and coulometric titration), Loss on drying, TOC, Conductivity

What we offer

Competitive salaries
401(k) plan with a company matching contribution
Medical, vision and dental
Health savings account (HSA)
Holiday/paid time off

Fulltime

Senior Research Associate

Seeking a QC Senior Research Associate with broad knowledge and expertise in ana...

Location

United States , San Diego

Salary:

60.00 - 69.00 USD / Hour

Beacon Hill

Expiration Date

Until further notice

Requirements

BS or equivalent in relevant discipline with a minimum of 2-5 years of relevant industry experience or Master’s degree in relevant discipline with a minimum of 0-1 years of relevant industry experience
Experience in pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role
Experience in optimizing methods with particular emphasis on cell-based potency assay, molecular biology assay, and protein chemistry assays
Significant experience in an FDA-regulated environment
Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic
Excellent organizational and communication skills

Job Responsibility

Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy analytical/molecular biology assays, chemical/biochemical assays, and cell-based biological potency assays, for process monitoring and product release and stability, e.g., compendial methods, HPLC, DLS, droplet digital PCR or qPCR, ELISA, and cell‑based potency assays
Participate in developing timelines, protocols and reports for assay transfers, qualifications/validations Contribute to establishing material specifications for drug substance and drug products
Author and review QC analytical/equipment SOPs, protocols, and reports as needed
Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports May act as an analytical lab representative on a CMC team
Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results within the company QMS according to established procedures.
Maintain QC laboratory, track critical reagents and equipment logbooks, and ensure all the equipment is calibrated
Utilize the LIMS system to submit samples, enter data, and track samples.
Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria.
Learn and become proficient in all laboratory instrument software to conduct testing

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

Select Country

Manager Quality Control - HPLC Labs

Amgen

Location:
United States , Juncos

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 18, 2025

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