Quality Control Stability Analyst Jobs

Experience: 1-3+ years of relevant work experience or equivalent combination of education and training

Skills: Proficient in Microsoft Office products, including advanced data functions in Excel.

Excellent analytical skills; Ability to collect and analyze data and present findings.

Strong organizational skills and attention to detail.

Strong verbal, written and interpersonal skills.

Charting for scorecard and governance packages.

Functional proficiency with an electronic Quality Management System

Perform studies to assist in qualification of QC test methods.

Experience in cell culture including aseptic technique

Experience with Good Documentation Practices

Perform QC release testing on cell and media products.

Write/review/revise SOPs related to quality control testing including test methods, equipment use, maintenance and calibration.

Three or more years of industry lab experience with HPLC, GC, GC/MS, LC/MS, ICP-MS, NMR required

GMP and ISO experience a plus

Hands-on experience with Biovia LIMS/LES system strongly preferred, Cheminformatics experience a plus

Must be able to multi-task in a fast-paced environment and possess strong verbal and written communication skills

Responsible for troubleshooting basic issues with supervisory oversight

Responsible for basic maintenance of equipment

Identify and escalate critical issues to the QC team lead and management team

A hybrid working model, allowing for in-office / work from home flexibility, generous vacation, personal and volunteer days

Competitive compensation packages including health and wellbeing benefits, retirement savings plans, parental leave, and family building benefits

Educational resources, matching gift, and volunteer programs

Manage a pipeline of assigned KYC file reviews ensuring that key deadlines are met

Recognized university degree and/or equivalent professional experience

In depth knowledge of anti-money laundering typologies, regulations, and guidance (BSA, KYC, etc.)

Superior oral and written communication/feedback skills

Proactive in partnering and communicating with Compliance/LOB partners.

Bachelors or advanced degree in business administration, criminal justice, intelligence studies or other related field of study

Bachelors in a scientific discipline, Associates in a scientific discipline (with additional experience) or equivalent level of knowledge, skills and abilities

Bachelors with 1 year of related experience or Associates with 2 years of related experience, or equivalent

Knowledge of laboratory practices required (such as aseptic technique, use of pipettes, pH etc.)

Good organization and documentation skills

Leading pay and annual performance bonus for all positions

34 Paid days off including vacation, sick days & company holidays

Participate in validation and technical transfer of analytical methods commensurate with experience

BA or B.S. degree in a science discipline required, or comparable experience

Prior experience related to method development/validation

Knowledge of pharmaceutical cGMP (US and EU) is preferred

Must have excellent verbal, written, interpersonal, and organizational and communication skills

Conduct routine and non-routine analytical, biochemical, and/or biological analysis such as, in-process materials, raw materials, finished goods, or stability samples

Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.

Minimum 1 year of related experience preferred

Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment would be ideal

Has technical problem-solving ability and analytical skills.

What Takeda can offer you:

Use laboratory instrumentation including analytical equipment, autoclaves, and incubators.

Review data, identify discrepancies, and escalate issues to management

Participate in method qualification/validation activities as necessary

Analyze, document, and report experimental data in accordance with Resilience requirements

Perform method transfer and qualification activities

2-5 years relevant life science experience

Experience in mammalian cell culture

Knowledge of calibration and operation of HPLC system with empower software.

Hands on experience in handling equipment like HPLC, Dionex, GC, UV Visible Spectrophotometer.

Write and review Standard Operating Procedures for assays and qualifications associated with timelines.

Knowledge on Analytical Method Validation.

BS, Life Science with minimum 2+ years of experience in HPLC

Good communication and writing skills.

Execute testing protocols for validations and qualifications.

Perform Routine and Non-Routine Analytical Quantitative tests by GC, HPLC and GC-Headspace. Including the preparation of calibration standards.

Perform analytical Lab data reviews.

Perform Special Testing according to Lab demand.

Work on Analytical Methods improvement, validation and transfer, when required.

Work on Lab investigations: OOS, NCI, DCT and CAPA, when required.

Strong knowledge and understanding of Managed Healthcare.

Ability to demonstrate initiative and discipline in time management and assignment completion

Bachelor’s degree in Finance or Accounting or equivalent experience.

Include minimum education, technical training, and/or experience preferred to perform the job.

Excellent communication skills, written and verbal.

Must display excellent interpersonal skills

Advanced Microsoft Office and SAP user experience preferred. Knowledge of LIMS and Trackwise preferred.

Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods.

Investigates all out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective action.

Prepares trend and metric laboratory reports in conjunction with the Microbiology Manager.

Review QC analytical assays including method qualification and validation assays.

Typically requires a bachelor's degree and 2+ years of related experience in a GMP QC role.

Important Skills: MS Office, LIMS, SAP, Trackwise, Waters Empower, Thermo Fisher Chromeleon, EDMS, compliance and science understanding.

What Takeda can offer you:

Perform and lead OOT, OOS, GMP Investigations, data analysis, deviation, and data trending.

Work in multiple departmental and cross-functional teams and projects; inspection and regulatory support.

Education Minimum Requirement with Experience

Experience with either vaccines, biologics, pharmaceuticals, or medical devices

Working knowledge of analytical methods, manufacturing processes, and Good Manufacturing Practice (GMP) Compliance

Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

BS in chemistry, biology or related discipline or equivalent combination of education and experience

0-2 years of experience in a laboratory environment

Conduct environmental monitoring in the clean space

Review data for compliance with specifications and GMP regulations

Plan and schedule work assigned to them

Writes/revises QC documents within their scope of expertise

Basic: 10-Key, Alphanumeric Data Entry, Contact Management, Database

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Intermediate: Accounting, Spreadsheet, Word Processing/Typing

The noise level in the work environment is usually moderate.

Bachelors in a scientific discipline, Associates in a scientific discipline (with additional experience) or equivalent level of knowledge, skills and abilities

Bachelors with 1 year of related experience or Associates with 2 years of related experience, or equivalent

Knowledge of laboratory practices required (such as aseptic technique, use of pipettes, pH etc.)

Good organization and documentation skills

Leading pay and annual performance bonus for all positions

34 Paid days off including vacation, sick days & company holidays

FDA regulated industry (food, pharmaceutical or medical device) experience is required.

Minimum of 3 years relevant experience required.

Strong work ethic and organizational skills.

MAIN JOB RESPONSIBILITIES / COMPETENCIES

Pay range is $65k to $85k - Final compensation will depend on experience.

High School diploma or GED.