Senior Manager, Quality Control Raw Materials Job at Beam Therapeutics (Durham)

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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

Senior Quality Manager

The Sr. Quality Manager in our manufacturing environment serves as the strategic...

Location

United States , Bourne

Salary:

Not provided

LI-COR

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Quality Management, or a related technical field is required
5+ years of quality experience in manufacturing, with at least 3 years in a leadership or ISO management role
Deep understanding of ISO 9001:2015 requirements and experience with tools like PPAP (Production Part Approval Process), FMEA, and SPC (Statistical Process Control)
Professional certifications such as ASQ Certified Manager of Quality (CMQ/OE), Certified Quality Engineer (CQE), or ISO Lead Auditor are highly preferred
Proficiency in Lean Manufacturing or Six Sigma (Green or Black Belt) to drive operational excellence

Job Responsibility

Develop, implement, and maintain a QMS that complies with ISO 9001/17025 or other industry-specific standards
Plan and lead internal audits
serve as the primary liaison for third-party registrar audits and customer quality inspections
Champion root cause analysis using methodologies like 5-Why, or DMAIC to address non-conformances and reduce scrap or rework
Oversee document control, ensuring all work instructions, quality manuals, and records are current and accessible
Lead and mentor a team of quality engineers, technicians, and inspectors to ensure standards are met at every production stage
Evaluate and monitor vendor performance, conducting supplier audits as necessary to ensure raw material integrity
Track and report on key performance indicators (KPIs) such as defect rates, First Pass Yield, and cost of quality to senior management

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

Senior Manager of Manufacturing Quality

The Senior Manager of Manufacturing Quality will manage the inspection of raw ma...

Location

United States , Huntsville

Salary:

Not provided

Yulista Holdings

Expiration Date

Until further notice

Requirements

Advanced degree with (3) years’ experience or a bachelor's degree with (5) years’ experience
Working knowledge and thorough understanding of aerospace quality standards such as AS9100/9110/9102 requirements
Strong analytical skills, problem solving techniques and statistical application experience
Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members
Experience with quality inspection equipment including go/no go, pin gauges, calipers, etc.
Ability to read and understand complicated blueprints
Thorough understanding of CMM operation/programming
Must be able to obtain and maintain a Government Security Clearance

Job Responsibility

Manage the inspection of raw materials, materials in process, and finished products
Oversee the development of quality standards and protocols for quality assurance testing models
Assist in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment
Responsible for evaluating internal controls and ensuring processes are acceptable, effective and in compliance with company policies/procedures, Quality Management System requirements, and Customer/Government requirements
Plan, coordinate, and direct manufacturing quality control program designed to ensure continuous production of products consistent with established standards
Establish/manage quality manufacturing department's business plan, budget, tactical strategies, roles and responsibility and standard work procedures to ensure achievement of key performance indicators (KPI)
Manage and ensure optimal utilization of all available resources (budget, workforce, processes and systems) for effective and efficient performance achievement through lean strategies
Formulate and maintain quality control objectives and coordinate objectives with production procedures in cooperation with other managers to maximize product reliability and minimize costs
Set department strategy and promote creation / update of efficient value-added processes for both inter and intra-departments
Perform managerial functions and other related duties as required to implement continuous process improvements in quality-related processes/procedures

Fulltime

Senior Scientist I, Quality Control

This position is within the Quality Control structure, under the Quality Organiz...

Location

United States , Verona

Salary:

90000.00 - 108000.00 USD / Year

Arrowhead Pharmaceuticals, Inc

Expiration Date

Until further notice

Requirements

M.S. in Chemistry (or related field) with 7+ years relevant laboratory experience
B.S. in Chemistry (or related field) with 9+ years of relevant laboratory experience
Fully knowledgeable of cGMP and ICH laboratory requirements and operations
Proficient and demonstrated experience with analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and typical cGMP policies/practices

Job Responsibility

Fully knowledgeable of cGMP requirements and ICH guidelines
Works independently to meet project timelines and deliverables with minimal supervision to no supervision
Collaborates routinely with Analytical Development on procedural method transfers and may participate in the execution of method validation protocols
Performs routine analytical testing of pharmaceutical raw materials, in-process samples, finished products and stability samples using established test methods and procedures
Proficient with various analytical instrumentation theory and practice
Executes training requirements for assigned SOPs and participates in department specific training modules
Independently completes complex instrumentation for testing according to written test methods and procedural documents to analyze samples
Demonstrates proficiency with a variety of instrumentation (e.g., HPLC, GC, LC-MS, KF, FTIR, Endotoxin plate readers, and/or Raman spectroscopy) and will assist in training on instrumentation
Is a subject matter expert in technical aspects of both instrumentation and workflow management and prioritization
Performs analyses in a timely and efficient manner to support ongoing prioritized studies

What we offer

competitive salaries and an excellent benefit package

Fulltime

Quality Manager

The Quality Manager will be responsible for ensuring that all products are manuf...

Location

United Kingdom , Rosyth

Salary:

Not provided

Mowi Poland

Expiration Date

Until further notice

Requirements

At least 2 years’ experience in a similar role
Internal Auditor training and experience
Demonstrable track record of delivering a high standard of work to agreed deadlines and an ability to work under pressure
Good written and verbal communication

Job Responsibility

Implementation of the Food Safety and Quality policies and procedures
Trend non-conformance findings to identify root cause for prevention of reoccurrence including via GMP auditing, customer complaints, micro results and internal non-conformances
Promoting and driving food safety and quality culture
HACCP – Identify risks and implement controls prior to the introduction of new products, processes, equipment or raw materials
Leading on the Technical aspect of NPD in preparation for new product launches
Lead, motivate and coach the QC/QA team to achieve continuous improvement
Driving Technical KPI standards and communicating findings to enhance best practice across the business
Escalating any relevant issues with the Senior Quality Manager

What we offer

Competitive salary and benefits package
A leadership role within a dynamic, growing FMCG manufacturing business
Significant opportunities for training, professional development and career progression
A collaborative, supportive and quality-focused working environment

Fulltime

Senior Manager, Manufacturing Operations

The Senior Manager of Manufacturing Operations is responsible for driving and su...

Location

United States , Rockville, Maryland

Salary:

113000.00 - 126000.00 USD / Year

Antech Diagnostics

Expiration Date

Until further notice

Requirements

MS degree in Biological Science or Biochemistry/Immunology
Minimum 10 years’ experience working in a regulated manufacturing environment
Project Management experience
Must have good understanding of diagnostic product manufacturing and operations
Experience with quality systems for diagnostic products (or other related, regulated manufacturing operations)
Experience interacting with regulatory agencies including audits, import/export, post-market surveillance, permitting, etc.
Ability to think strategically to align and identify needs with incoming portfolio opportunities
Flexibility to be able to work in a cross-functional, multi-disciplinary environment
Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results in a fast-paced, interdisciplinary team-based environment
Strong commitment to product quality and continuous improvement

Job Responsibility

Responsible for overall operational execution including, but not limited to, planning, scheduling, manufacturing, warehouse, and facility operations with a focus on quality, availability, inventory controls/system and manufacturing costs
Lead and drive the successful execution of Operational, Manufacturing and Quality initiatives in conjunction with strategic business plans
Provide regular project status information to team members, including preparing project plans, scheduling and attending required meetings, and following up on action items
Develop and implement effective and strategic business solutions through research and analysis of data and business processes
Develop or assist in the development of work plans and task sequencing
Develop or assist in the development of training materials and training records for staff
Serve as a resource for internal team members for expedited problem identification and resolution, provision of project-specific updates, and team interactions and deadlines
Maintain all relevant documentation and communications to support goals
Manage resources and prioritize responsibilities as aligned with business needs to include running the business activities, project support, and continuous improvement activities
Creation of processes for operational efficiencies including planning and MRP control systems

What we offer

Paid Time Off & Holidays
Medical, Dental, Vision (Multiple Plans Available)
Basic Life (Company Paid) & Supplemental Life
Short and Long Term Disability (Company Paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts

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

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Senior Manager, Quality Control Raw Materials

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