Social network you want to login/join with:
QA Associate - QA Operations Batch Review
Job Profile
Grade 7
Primary Location *
Slough
Additional Location(s)
N/A
Role Purpose & Scope *
(Why does this job exist and what scope does it cover?)
· Enable site operations performance by managing and supporting GMP issues through QMS processes, site governance, and senior QA leadership.
· Ensure that quality is maintained at an appropriate level meeting customer and regulatory expectations, enabling the Lonza Slough Site to meet relevant targets. This is achieved by assessing compliance with site PQS and GMP auditing documentation during manufacturing, development, and laboratory processes, escalating non-compliance through appropriate channels.
· Support Senior QA leadership in driving continuous improvement.
· Maintain compliance with Regulatory Authorities, Global Quality standards, and Customer expectations.
Responsibilities *
(Define specific short & long-term work duties starting with the most frequent and impactful)
· Review documentation generated during manufacturing, development, and laboratory processes.
· Advise on best practices for document completion, review, follow-up actions, and escalation if necessary.
· Act as a point of contact for general Quality queries and escalate as required.
· Use knowledge of quality procedures to identify and report non-conformances, resolving issues via interaction with relevant personnel.
· Manage and escalate major and critical compliance issues through the site QMS, including deviations and CAPAs.
· Participate in continuous improvement activities.
· Mentor and coach team members in cGMP practices to maintain a compliant environment.
· Maintain audit readiness.
· Contribute to PQS process improvement initiatives and projects.
Skills
· Proficient in MS Office (Word, Explorer, Excel, Access, Outlook) and database management.
· Strong verbal and written communication skills.
· High attention to detail in data entry.
· Ability to prioritize workload, make decisions, and meet deadlines.
· Good organizational and planning skills.
Agility
· Willingness to learn from experience and adapt.
· View errors as learning opportunities.
· Open to new challenges and change.
Business Acumen
· Understands corporate strategy and its impact on the business area.
· Uses business knowledge to make informed decisions.
· Shares information openly and collaborates effectively.
· Maintains professionalism and respect towards colleagues and customers.
Customer Focus
· Understands customer needs and feedback.
· Acts to improve customer satisfaction within role scope.
Driving Results
· Consistently meets goals and KPIs.
· Demonstrates persistence and motivation.
· Ensures quality standards are upheld while delivering results.
· Prioritizes and organizes work effectively.
Leadership
· Ensures safety for self and others.
· Takes responsibility for personal actions.
· Seeks feedback for self-improvement.
· Contributes positively to the work environment.
· Demonstrates reliability and dependability.
Qualifications
Education/Degree
· Bachelor of Science or equivalent experience.
Field of Study
· Biology or related field.
Work Experience
· Previous QA/GMP experience is useful but not essential.
Level
· Advanced, with 5-10 years of experience.
Other Requirements
· Knowledge of quality procedures, non-conformance reporting, and issue resolution.
· Commitment to maintaining a safe working environment and actively identifying safety risks.
#J-18808-Ljbffr