QC Lab Support Supervisor

Orion Group Life Sciences are currently recruiting a QC Laboratory Support Supervisor (Onsite) on behalf of our Multinational Biopharmaceutical client based in Sligo on an initial 12-month contract with huge potential to extend.
 
Job Summary:
To provide an effective testing and analytical service to the plant ensuring that products manufactured are tested to specification on time and plant quality and safety goals are met.
Ensure that all raw materials, in-process, finished product, stability and contract testing and is carried out per schedule and records are maintained to appropriate requirements. Ensure that technical and systems excellence is maintained in the laboratory by ensuring own skills are maintained, by coaching and training analysts to ensure right first-time behaviour and by implementing improved working practices in terms of efficiency, compliance and Right First Time.
This position will take full responsibility for Compliance. Documentation, equipment maintenance and Training within the QC Lab. Other responsibilities may be assigned as required.
 
Responsibilities:

• Ensure Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
• Understand Regulations and business processes required to maintain Laboratory Data Integrity.
• Ensuring that analysts working in the assigned cell or team are performing to the best of their ability, coaching and providing guidance where issues occur such as poor set-up or test execution performance.
• Improving the overall efficiency and velocity within the assigned team.
• Ensuring that the agreed compliance timelines, such as CAPA due dates are adhered to and identify recovery paths when required. to bring test schedules back into alignment with plant requirements.
• Identifying weaknesses in laboratory performance and working with the laboratory manager to rectify.
• Resolving analytical OOS issues and/or deviations as they arise in a timely manner both through practical work and through Soltraqs.
• Acting as designee for the Laboratory Manager as assigned.
• Ensuring 6S excellence is maintained across the Laboratory.
• Instilling a quality culture of Zero, Believe it, Achieve it amongst the QC laboratory team
• Ensuring that all laboratory test equipment is utilised and maintained correctly.
• Executing and / or supporting projects as assigned by the laboratory manager.
• Developing and changing of in-house laboratory procedures as appropriate.
• Positively contribute to departmental programs such as CI, BEx and RFT.
• Supports the transfer of new products.
• Completes project work.
• Adheres to and supports all EHS & E standards, procedures, and policies.
• Ensuring adherence to Compendia testing requirements and implementing changes as required.
• Performance of document periodic reviews
• Development and review of training material.
• Ensuring all Laboratory equipment is calibrated on time and is fit for use at all times.

Supervision Received

• Operates in an environment which is essentially self-managed but with supervision through the Laboratory Manager.
• Will liaise with Laboratory supervisors and Laboratory manager the meet department testing timelines.
• Goals are reviewed on a regular basis

Supervision Provided

• Provides supervision to 2-12 Direct reports.
• Is responsible for setting annual goals, completing reviews, growth plans and performance management of the team.

Qualifications:

• 3rd level qualification in a relevant Science discipline.
• Minimum 4 years analytical experience in the pharmaceutical industry.
• Proven track record in an analytical role. Must be expert in HPLC, GC, LCMS, GCMS, Automatic titration, Identification techniques.
• Strong knowledge on regulatory requirements.
• Proficient in using analytical equipment in the QC lab.
• Involvement in product transfers / method transfer experience preferred.

Cognitive/Business Skills

• Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures.
• Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
• Requires proven problem solving skills and the ability to adapt to new requirements.
• Is results driven striving to meet all targets and metric standards as set by department/site and division leaders.
• Prioritises their own and their teams work in line with business demands.
• Requires total commitment to quality and maintaining a high standard of work at all times.
• Demonstrates the highest levels of integrity and a strong work ethic at all times.
• Strong communication skills both verbal and written are required for the execution of this role.
• Strong interpersonal skills are required.
• Supports the principles of Perfect Performance.

Ownership/Accountability

• Responsible for the smooth and efficient running of the Laboratory and supervising the work of direct reports.
• Responsible for presenting and taking ownership of own area during regulatory inspections and corporate audits.
• Demonstrates tenancy in the closure of issues and meeting project deadlines.
• Must ensure that all work carried out meets cGMP standards and that all quality records will meet inspection and audit scrutiny.
• Demonstrates an ethos of Right First Time at all times.
• Ensuring team compliance to procedures, policies and guidelines ensuring adherence with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines as all times.

Influence/Leadership

• Leads and gives direction to direct reports.
• Is a site SME on all Analytical and compliance issues and provides guidance on same.
• Contributes to the successful delivery of site C.J.R.s and Goals.
• Leads the delivery of new Analytical initiatives.
• Promotes department goals by selecting, motivating, and training capable staff.
• Leads the activities of assigned staff by communicating and providing guidance towards achieving department objectives.
• Contributes to Talent Management of teams within the organization and to the development of the team to meet evolving business needs.

Decision Making/Impact

• Expected to handle all compliance. Documentation, training, and equipment related tasks. If problems occur, the Lab support supervisor is required to investigate and tackle independently.
• Responsible for the presentation of data to stakeholders to ensure prompt decisions on deviations within the QC Lab.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.