1. Job Details

Supervisory Organization*

QA Operations

Reports to position*

Associate Director, QA

Job Title*

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 and to enable the Lonza Slough Site to deliver to relevant targets. This will be achieved by assessing compliance to site PQS and principles of GMP auditing documentation generated during manufacturing processes, development and laboratory processes and where required escalating non-compliance through the PQS, site governance mechanisms and senior QA Leadership.

· Supporting Senior QA leadership to drive continuous improvement.

· Maintaining compliance with Regulatory Authorities requirements, Global Quality standards and Lonza's Customer expectations.

Key

Responsibilities*

(define specific short & long-term work duties starting with the most frequent and impactful)

· To provide shoulder to shoulder review of documentation generated during manufacturing processes, development and laboratory processes.

· Advise areas of support on best practice for document completion, review and follow up actions/ escalate if required.

· Acting as a point of contact for general queries relating to Quality and escalating as required.

· Expand and utilize knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel.

· Utilize knowledge of GMP and quality processes within the functional areas to manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAs.

· To actively identify, suggest and participate in continuous improvement activities

· Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment.

· Maintain and promote a state of audit readiness.

· Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects.

Required Skills & Competencies*

(e.g. technical, interpersonal, problem solving)

Skills

· IT literate (MS Office - Word, Explorer, Excel, Access, Outlook) familiarity with database entries

· Verbal and written communication skills

· Risk based decision making

· PQS experience

· Accurate data entry skills, high attention to detail

· Demonstrated workload prioritization skills, decision making and scheduling skills

· Ability to meet strict deadlines

· Good organizational and planning skills.

Competencies

Agility

· Demonstrates an ability and desire to learn from experience

· Treats errors as a learning opportunity

· Is willing to take on new challenges

· Takes steps to adapt thinking and behavior to support change

Business Acumen

· Seeks to understand the corporate strategy and how his/her business area contributes to the company's success

· Understands the impact of his/her own actions on his/her business area

· Expresses ideas that will improve his/her business area

· Uses knowledge of his/her business area to make accurate and timely decisions

Collaboration

· Works as an active member of his/her team

· Generously shares information and knowledge with others on the team

· Demonstrates an openness to different perspectives by balancing listening and speaking

· Treats all co-workers and customers professionally and with respect

Customer Focus

· Understands what internal and/or external customers need from him/her to deliver in his/her respective role

· Demonstrates an openness to receiving customer feedback

· Takes action to enhance customer satisfaction within the scope of his/her role

Driving Results

· Consistently delivers goals while monitoring KPIs with supervisor

· Demonstrates persistence and motivation to overcome obstacles and challenges

· Ensures quality standards are maintained while delivering results

· Plans, prioritises and organises work to deliver on time

Leadership

· Takes responsibility for his/her safety and that of others

· Takes responsibility for personal choices and behaviours

· Seeks feedback and reflects on his/her development needs in order to continuously improve

· Contributes to a positive work environment

· Acts as a reliable and dependable member of the team

2. Qualifications (Min. requirements to perform assigned tasks)

Education/Degree

Required*

Bachelors of Science (or equivalent experience)

Field of Study

Biology or related field

Work Experience (If UK location - NO years of experience should be included)

Area*

Previous work experience in QA / GMP experience is useful though not essential

Level*

Advanced - 5-10 years

Other Requirements

· Quality : Utilising knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel. Obtaining confirmation on any issue of which unsure

· Safety : Maintaining a safe working environment for self and all employees. Actively identifying potential safety risks and working to mitigate these.