Associate Scientist II, Quality Control

The Associate Scientist II Quality Control supports and independently executes quality control activities for microbiological next generation sequencing biologics and related products. The role applies established technical knowledge to perform and troubleshoot routine and moderately complex laboratory workflows analyze and communicate results support investigations and process improvements and maintain compliance with the quality management system. This position works closely with Manufacturing Process Development Quality Assurance and operational partners.

To perform this job successfully an individual must be able to capably perform each of the following essential duties: 

• Independently execute routine and moderately complex QC testing and operational workflows to support production schedules product release development activities and customer requirements

• Identify assay documentation and process improvement opportunities through first-hand observation and data review; implement approved improvements and contribute technical input to change activities

• Perform primarily tactical laboratory work with responsibility for planning assigned daily activities prioritizing work and completing defined technical assignments with limited day-to-day direction

• Collaborate with local QC Manufacturing Process Development Quality Assurance and Operations partners; provide reliable technical information to support cross-functional work

• Document laboratory activities and quality records clearly; summarize results observations risks and recommended next steps to technical staff peers and leadership

• Provide task-level guidance peer support and on-the-job training to less experienced team members when assigned

• Own assigned workflows test methods equipment or product-family activities within established procedures; support scheduling readiness documentation and issue resolution

• Apply working knowledge of microbiology molecular biology analytical methods aseptic technique and standard laboratory equipment; serve as a developing technical resource in assigned areas

• Participate in and independently complete defined improvement projects lean initiatives investigations and corrective or preventive action activities

• Process review trend and interpret test data using approved methods and good documentation practices; contribute to reporting of quality productivity right-first-time and other relevant performance indicators

• Perform laboratory and light manufacturing activities requiring repetitive hand movement close visual work standing walking and handling materials in accordance with the physical requirements below

• Perform work in accordance with approved SOPs work instructions applicable regulatory requirements ISO 13485 quality system requirements safety expectations and PPE policies

• Perform other duties as required or assigned by management to meet business needs

Qualifications :

Essential Knowledge and Qualifications:

• Bachelors degree in a relevant life sciences field such as molecular biology microbiology biochemistry or a related discipline with relevant laboratory or industry experienceor an equivalent combination of education and applicable work experience.

• Experience independently executing laboratory workflows in a regulated production biotechnology pharmaceutical or medical-device environment.
• Demonstrated capability with applicable biological techniques which may include cell-based assays enzyme activity assays ELISA PCR next generation sequencing microbiology and aseptic technique.
• Demonstrated capability with applicable analytical techniques which may include electrophoresis chromatography mass spectrometry or spectroscopy.
• Ability to operate standard laboratory equipment and to process record review and interpret data using approved methods and good documentation practices.
• Ability to follow SOPs and work instructions recognize deviations or atypical results perform initial troubleshooting and escalate appropriately.
• Experience contributing to investigations process improvements method updates or controlled documentation.
• Effective written and verbal communication skills and the ability to work successfully on cross-functional teams.
• Working knowledge and proficiency with Microsoft Office particularly Outlook Word and Excel.

Desired Knowledge and Qualifications:

• Two or more years of relevant laboratory or industry experience in biotechnology pharmaceutical medical-device or regulated manufacturing operations.
• Experience with ISO 13485 or a comparable regulated quality management system.
• Experience writing or revising SOPs work instructions test methods or manufacturing protocols.
• Experience supporting investigations corrective and preventive actions statistical analysis method transfer validation or implementation of new technical processes.
• Experience providing task-level training or technical guidance to peers.

Behavioural and Interpersonal Competencies:

• Resonate and operate in line with LGCs core value behaviors: Passion Curiosity Integrity Brilliance and Respect.
• Work with a high degree of accuracy attention to detail reliability and professional judgment.
• Demonstrate autonomy by organizing assigned work taking initiative and recognizing when stakeholder engagement or escalation is appropriate.
• Apply analytical problem-solving skills to organize information interpret results and recommend effective action within the scope of the role.
• Communicate clearly and respectfully with technical staff peers cross-functional stakeholders and leadership.
• Adapt to changing priorities while managing multiple tasks in a dynamic laboratory environment.
• Promote cooperation accountability and commitment within the team to achieve goals and deliverables.
• Demonstrate a continuous-improvement mindset and willingness to learn new methods technologies products and responsibilities.
• Meet quality safety schedule and productivity expectations while maintaining compliance with approved procedures.

Additional Information :

LGC is a leading global life science tools company providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications which are typically embedded and recurring within our customers products and workflows and are valued for their performance quality and range. 

OUR VALUES

• PASSION
• CURIOSITY 
• INTEGRITY
• BRILLIANCE
• RESPECT

EQUAL OPPORTUNITIES 

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age disability race color ethnic or national origin sex sexual orientation gender reassignment marital or civil partnership pregnancy or maternity religion or belief. Short listing interviewing and selection will always be carried out without regard to gender sexual orientation marital status color race nationality ethnic or national origins religion or belief age or trade union membership.

All your information will be kept confidential according to EEO guidelines.

For more information about LGC please visit our website 

#scienceforasaferworld 

Remote Work :

No

Employment Type :

Full-time