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Catalent · 1 hour ago

Quality Control Analyst II

Chelsea, MA

Full-time

Onsite

Entry, Mid Level

$73K/yr - $96K/yr

2+ years exp

Catalent, Inc. is a leading global contract development and manufacturing organization dedicated to supporting product development and supply for pharma, biotech, and consumer health customers. The Quality Control Analyst II is responsible for executing QC testing and related analytical activities, including routine and non-routine chemical and physical analyses of materials, ensuring compliance to specifications and documenting results.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Performs analytical testing of spray dried powder using relevant methodologies (i.e. Delivered Dose, Anderson Cascade Impaction, Next Generation Impaction)

Operates analytical instrumentation (i.e. Liquid Chromatography such as HPLC, UPLC, Gas Chromatography (GC), UV-vis, FTIR, laser diffraction, Karl Fischer)

Statistically and critically analyzes data for trending and reporting into regulatory filings

Participates in Laboratory and/or Quality Investigations and construction and/or revision of Standard Operating Procedures (SOPs)

Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration

Assists in the writing and updating of analytical test procedures, protocol, log books and checklists

Responsible for identifying and alerting a supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions

All other duties as assigned

Qualification

Analytical testingManufacturing Practices (GMP)QC test methodsHPLCStatistical analysisAnalytical method developmentTroubleshooting instrumentationRoot cause analysisTeam collaboration

Required

Bachelor's Degree required. Preferably in Physical or Chemical Sciences (life sciences) with a minimum of two years of relevant work experience required

Minimum of 1 year of regulated Good Manufacturing Practices (GMP) environment experience required

Extensive experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses required

Demonstrated ability to lead and/or author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required

Preferred

Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred

Ability to troubleshoot and repair analytical instrumentation such as HPLCs and UPLCs preferred

Experience with analytical method development and validation preferred

Benefits

Defined career path and annual performance review and feedback process

Diverse, inclusive culture

Positive working environment focusing on continually improving processes to remain innovative

Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

152 Hours + 8 paid holidays

Several Employee Resource Groups focusing on D&I

Dynamic, fast-paced work environment

Community engagement and green initiatives

Generous 401K match

Company match on donations to organizations

Medical, dental and vision benefits effective day one of employment

Tuition Reimbursement – Let us help you finish your degree or start a new degree!

WellHub program to promote overall physical wellness

Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2022 (1)