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

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

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

Manager QC (Separation Sciences)

This job specification outlines the general responsibilities associated with the...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a Science related field is required
6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry
2 – 3 years of specific QC laboratory management experience is desirable
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating
Proven experience of leading teams
Broad technical knowledge within Separation Sciences area
Specific knowledge HPLC, Capillary Electrophoresis and SDS/IEF Gels is an advantage
Managerial/Supervisory experience with a proven record in a Supervisor/ Team Lead role
Experience leading cross-functional teams is desirable

Job Responsibility

Supervision/Management of QC Separation Sciences including In-process team
Ensure the Separation Sciences area is operated in a safe manner
Ensure all testing is performed in accordance with relevant procedures and within the required due date
Develop, revise and implement procedures that comply with appropriate regulatory requirements
Out of hours responder for Separation Sciences equipment (fridges /freezers / incubators)
QC Representative for Separation Sciences at Amgen network meetings
Developing and coaching the QC Separation Sciences team
Ensure timely completion of lab investigations and deviations through the relevant procedures
Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to Separation Sciences
Participate in regulatory agency inspections as required

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

Quality Lab Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

64000.00 - 88000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor degree in Chemistry or physical science with 2 or more years' experience
Must have good oral and written communication skills, strong analytical skills and be detail oriented
Knowledge of current Good Manufacturing Practices is preferred
Advanced laboratory skills with basic knowledge of statistical methods
Strong technical problem solving skills
Ability to handle multiple tasks concurrently, and in a timely fashion
Knowledge of Empower Chromatography Data System and LIMS is preferred but not required
Knowledge of GLP, cGMP requirements and familiarity with USP/ICH guidelines is preferred but not required
Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation, and task completion
Ability to work independently and as part of a team, self-motivated, demonstrates adaptability, and possesses a positive attitude in a highly dynamic environment

Job Responsibility

Conduct critical chemical and physical analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at the Round Lake manufacturing facility
Work under minimum supervision
Serve as mentor to Quality Laboratory Associate (QLA) I positions
Provide training and work direction for QLA I positions as required
Perform review of test data, which includes overall documentation practices
Perform release functions in LIMS or other computerized systems
Use sophisticated laboratory instrumentation (e.g., HPLC, GC) and computer systems to collect and record data
Perform advanced chemical assays requiring precise analytical skills and understanding of biology and chemistry principles
Complete all testing, including special project / protocol testing in a timely and appropriate manner
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Quality Lab Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

64000.00 - 88000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor degree in Chemistry or physical science with 2 or more years' experience
Must have good oral and written communication skills, strong analytical skills and be detail oriented
Knowledge of current Good Manufacturing Practices is preferred
Advanced laboratory skills with basic knowledge of statistical methods
Strong technical problem solving skills
Ability to handle multiple tasks concurrently, and in a timely fashion
Knowledge of Empower Chromatography Data System and LIMS is preferred but not required
Knowledge of GLP, cGMP requirements and familiarity with USP/ICH guidelines is preferred but not required
Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation, and task completion
Ability to work independently and as part of a team, self-motivated, demonstrates adaptability, and possesses a positive attitude in a highly dynamic environment

Job Responsibility

Conduct critical chemical and physical analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at the Round Lake manufacturing facility
Work under minimum supervision
Serve as mentor to Quality Laboratory Associate (QLA) I positions
Provide training and work direction for QLA I positions as required
Perform review of test data, which includes overall documentation practices
Perform release functions in LIMS or other computerized systems
Use sophisticated laboratory instrumentation (e.g., HPLC, GC) and computer systems to collect and record data
Perform advanced chemical assays requiring precise analytical skills and understanding of biology and chemistry principles
Complete all testing, including special project / protocol testing in a timely and appropriate manner
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

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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