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Catalent · 1 day ago

Quality Assurance Specialist

St. Petersburg, FL

Full-time

Onsite

Mid Level

3+ years exp

Catalent is a global drug development and delivery leader, seeking a Quality Assurance Specialist to manage and document product and process discrepancies. The role involves collaborating with manufacturing personnel to maintain compliance with Good Manufacturing Practices and overseeing quality assurance processes.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Collaborates with management and supervisory personnel from Operations, Quality Control and Quality Assurance to resolve problems affecting product quality; collaboration includes reacting, investigating and following up with Operations for non-conformance issues and a working jointly towards resolution

Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP and lead investigations of non-compliant issues according to procedures as defined by SOPs

Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure

May author other types of quality system documents as directed or assigned by QA management

Liaise with customers to ensure customer requirements are satisfied

Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure

Prepare annual product reports and ensure on time closure

Other duties as assigned

Qualification

Quality AssuranceCGMP knowledgeInvestigation writingRoot cause analysisReport writingCollaborationProblem-solvingAttention to detailTime management

Required

Bachelor's Degree in Science or related field required (Chemistry, Microbiology or Biology)

A minimum of three years related experience in QA pharmaceutical manufacturing

Prior experience working with investigation writing, including root cause analysis and report writing a must

Working knowledge of cGMPs and/or OSHA regulations required

Ability to work effectively under pressure to meet deadlines

Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance

Be accessible to manufacturing floor and office staff and to use required office equipment

Specific vision requirements include reading of written documents and frequent use of computer monitor

Preferred

Prior experience with preparing annual product reviews

Benefits

Competitive medical benefits and 401K

152 hours of PTO + 8 Paid Holidays

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)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2022 (1)