QA Associate

Job Title: QA Associate

Job Type: 9 Month Contract

Hours of work: Mon - Fri

Industry: Pharmaceuticals

Location: Slough, England

Salary: 23.08

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.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.