QA Specialist, Operations - 2nd shift

Lonza, Inc.•Tampa, FL

28d

About The Position

Developing professional who assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing. Alternatively, conducts internal production/process and manufacturing quality control audits and risk assessments.

Requirements

Bachelors Degree in a Science or related field
3+ years of relevant work experience
Pharma cGMP preferred
Trackwise, SAP, and Microsoft Office preferred

Responsibilities

Performs document reviews of SOPs, batch records, test methods, protocols, deviations, CAPA, component specification and logbooks to ensure cGMP activities are completed and documented in accordance with approved, written procedures.
May also review raw materials, work orders, validation and MSAT reports. Approves SOPs, Master Batch Records and executed batch records.
Approves / Releases Laboratory Data and Reports.
Assesses potential impact to product quality for open deviations during lot release.
May participate in investigations into minor and major root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity.
Participates in internal audits, vendor audits and customer audits. Provides back room support during regulatory audits and inspections.
May lead internal or external audits. Interact with different departments to solve issues to achieve department goals. Support all areas to achieve company goals.
Attend client meetings and calls
Perform additional job-related assignments as requested by management
Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
Stop work where deemed necessary to maintain safety