Associate Principal QA Specialist

Job Title: Associate Principal QA Specialist
Contract: 12 months
Location: Slough (onsite) - potential for hybrid after training complete
Salary: £31.99 PAYE, £40.47 Umbrella per hour (Inside IR35)
Hours: 37.5 hours per week

1. Job Details
   
   Supervisory Organization*
   
   QA Technical Operations
   
   Reports to position*
   
   QA Manager (QA Technical Support)
   
   Job Title*
   
   Associate Principal QA Specialist, QA Technical Operations
   
   Job Profile
   
   N/A
   
   Primary Location*
   
   Slough
   
   Additional Location(s)
   
   None
   
   Role Purpose & Scope*
   
   (why does this job exist and what scope does it cover?)
   
   · Support Operations to ensure Compliance to GMP
   
   · Manage and support GMP issues through QMS processes, site governance and senior QA leadership.
   
   · Act as a GMP SME by implementing, managing and enforcing quality processes on site.
   
   · Supporting Senior QA leadership to drive continuous improvement and 'fitness for purpose'. Maintaining compliance with Regulatory Authorities requirements, Global Quality standards and our clients Customer expectations
   
   Key
   
   Responsibilities*
   
   (define specific short & long-term work duties starting with the most frequent and impactful)
   
   · To provide shoulder to shoulder review, approval and support to key business partners for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations, OOS.
   
   · 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 and quality culture
   
   · Maintain and promote a state of audit readiness
   
   · Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects
   
   · Provide QA SME support at departmental Local Quality Councils and project meetings
   
   · Provide QA SME Support for manufacturing during out of hours
   
   · Performs other duties as assigned.
   
   Key Metrics*
   
   Organization Size
   
   (# of direct/indirect reports)
   
   Financial responsibility
   
   (e.g. budget, Revenue)
   
   0
   
   None
   
   KPI Targets (in addition to abiding relevant quality systems standards (ISO 9001, ISO 13485) & where relevant complying to applicable pharmaceutical GMP standards (US and European) / 21CFR820 as well as abiding & role modelling for all Health, Safety and Environmental rules and guidelines)
   
   · Deviation assessment completed within 2 days
   
   · Zero overdue quality records
   
   Key Stakeholders*
   
   Please specify the stakeholder positions the role will interact with
   
   · Manufacturing Operations (Cell Banking, Fermentation, Purification and Manufacturing Support)
   
   · Warehouse and Supply Chain
   
   Required Skills & Competencies*
   
   (e.g. technical, interpersonal, problem solving)
   
   · Excellent decision-making and problem solving skills.
   
   · Strong Quality mindset
   
   · Strong business and interpersonal skills and be a persuasive communicator in written, oral and active listening to influence peers and colleagues.
   
   · Strong Continuous Improvement mindset
   
   · Excellent communication skills (verbal and written).
   
   · Ability to meet strict deadlines.
   
   · Excellent organizational and planning skills.
   
   
2. Qualifications (Min. requirements to perform assigned tasks)
   
   Education/Degree
   
   Required*
   
   Scientific
   
   Field of Study
   
   Scientific
   
   Preferred
   
   N/A
   
   Field of Study
   
   N/A
   
   Language(s)
   
   Required*
   
   English
   
   Ability Level
   
   2 - Business Fluent
   
   Preferred
   
   N/A
   
   Ability Level
   
   Choose an item.
   
   Certifications (incl. professional qualifications) i.e. ACCA, GPHR, CIPS, PgMP
   
   Required
   
   N/A
   
   Issuer
   
   N/A
   
   Preferred
   
   N/A
   
   Issuer
   
   N/A
   
   Work Experience (If UK location - NO years of experience should be included)
   
   Area*
   
   Quality (QA or QC)
   
   Level*
   
   Advanced - 5-10 years
   
   Area
   
   N/A
   
   Level
   
   Choose an item.
   
   Other Requirements
   
   · None
   
   Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy