QC Specialist I-Sample Management at Lonza - Spain

Portsmouth, New Hampshire, United States -

Full Time

Start Date

Immediate

Expiry Date

30 May, 26

Salary

0.0

Posted On

01 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Sample Management, Cell Bank Management, Documentation Management, Aseptic Technique, GMP Documentation, Data Integrity, cGMP Knowledge, GDP Knowledge, Problem Solving, Attention To Detail, Critical Thinking, Risk Assessment, SAP, TrackWise, Microsoft Word, Microsoft Excel

Industry

Pharmaceutical Manufacturing

Description

QA Specialist I-Laboratory Information Location: This position is based in our Portsmouth, NH office. The standard schedule for this role is second shift, Wednesday through Saturday, from 1:00 PM to 11:30 PM (EST). What you will get: Below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge. What you will do: QC Laboratory Information Specialists support the Quality Control group by managing samples, cell banks and documentation for the department. Performs sample receipt and storage, coordinates / performs shipments to external customers and testing sites, performs controlled copy printing and assay form creation along with reconciliation of each. Receive, ship and release cell bank vials, follow through on action items and participate in problem solving of issues. Additionally, aseptically performs bulk dispenses for final product, customer samples and Stability samples. Perform sample receipt and sample storage. Segregate samples appropriately and ensure testing samples are placed in the correct location / lab. Processes retain samples into appropriate locations for long term storage. Performs annual inventories of retain samples, and annual defrosts of temperature chambers. Perform controlled copy prints of SOPs and Test Methods and create assay forms for the lab. Manage the document process to include creation, periodic review to ensure current versions and adequate stock, to archival of records. Participate in the receipt and shipments of cell banking vials. Participate in the support of manufacturing with vial releases. Practice good aseptic techniques during sample dispensing. Creation, revision and review of GMP documentation. Works well within the team, showing an eagerness to learn and grow. Escalates potential quality issues to co-workers and/or area leader. Follows SOP’s, does not deviate from procedure. Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures. Understands cGMP and GDP. Understands how to determine schedule for the day, completes routine tasks efficiently and accurately. Perform other duties as assigned. What we are looking for: Proficiency with Microsoft Office tools (Word, Excel, Outlook); experience with SAP and TrackWise preferred. Working knowledge of cGMP regulations and guidelines (e.g., ICH Q7, 21 CFR Parts 210/211, 820). Strong attention to detail, critical thinking, and problem-solving skills. Demonstrated ability to identify nonconformances, assess risk, and escalate issues appropriately with or without guidance. Motivated self-starter with the ability to adapt to changing priorities and manage multiple deliverables. Ability to work effectively both independently and within a team environment. Clear and logical communication skills with the ability to present facts, understand differing perspectives, and collaborate across functions. Experience supporting batch release, product disposition, labeling systems, and regulatory or customer audits preferred. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.

Responsibilities

QC Laboratory Information Specialists support the Quality Control group by managing samples, cell banks, and documentation, which includes performing sample receipt, storage, and coordinating shipments. Responsibilities also involve aseptically dispensing bulk product, managing controlled copy printing, assay form creation, and participating in the creation and review of GMP documentation.