Associate II, Quality Control

PSG Global Solutions; Durham (NC); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading healthcare recruitment firm is seeking a QC Associate I/II to support key operational aspects of their QC Microbiology group. This role involves performing testing and adhering to GMP requirements, alongside responsibilities for documentation and technical leadership. The ideal candidate should have a relevant degree and experience in quality systems. You'll engage in method development and ensure integrity in laboratory results, contributing to improvements in analytical methods.

Qualifications

• 0-2 years of relevant experience required for Associate I with a B.S. degree.
• 8+ years of relevant experience required for Associate I with an A.S. degree.
• 2-3 years of relevant experience required for Associate II with a B.S. degree.
• 4 years of relevant experience required for Associate II with an A.S. degree.
• 0-2 years of relevant experience required for Associate II with an M.S. degree.

Responsibilities

• Support key functional and operational aspects of the QC Microbiology group.
• Perform testing and associated activities.
• Adhere to GMP requirements and documentation practices.
• Perform sample approval as agreed.
• Support maintenance of laboratory systems.

Skills

Organizational skills

Problem-solving skills

Communication with peers and management

Instrument/method troubleshooting skills

Multi-tasking capabilities

Education

B.S. degree

M.S. degree

A.S. degree

Job description

At Real we're always looking for new and ambitious people to help deliver exceptional service levels, change the lives of the candidates we represent and partner with some of the world's best pharmaceutical, biotechnology and medical companies.

As specialists in recognising talent we pride ourselves on not just finding the best people for our client partners but on our ability to spot the best and brightest talent to work for us. We are also renowned for providing training and long-term career opportunities to help our employees be the best they can be, so they can continue to deliver the expertise Real has become famous for.

Relationships are at the heart of everything we do and ensure that our clients and candidates continue to work with us again and again. This ethos is also what shapes how we work as a business. We encourage and reward knowledge sharing and have various support networks and international forums to enable our employees to keep up-to-date with changes happening across their industries and share local insight to deliver true global perspectives.

Job Description

• The QC Associate I/II is responsible for supporting key functional, tactical, and operational aspects of the QC Microbiology group at Biogen.
• Performs testing, and all associated activities associated with this testing.
• Responsibilities include, but are not limited to, training, testing support, support for qualification/validation/certification activities as appropriate, robust and compliant cGMP documentation practices.
• A fundamental understanding of the Biogen Quality Systems and able to apply it in their daily support functions.
• Adherence to all GMP requirements, familiar with FDA/EMA resources, effective interactions/communication with Quality management, personal development, and support of investigations.
• Able to work effectively within the group.
• Perform testing, initiate deviations, IA, and A/A. Capable to perform up to 60% of the assays in the group.
• May author or design protocols, change control requests, and Quality Technical Reports, as directed etc. perform document revision. Provides technical leadership as a subject matter expert in one or more disciplines.
• Provides timely review/corrections for data and documentation. Perform sample approval according to agreement.
• Participates in the execution of method development, method qualification, facility certification, analytical improvement projects, and validation of analytical methods in collaboration with teams as appropriate.
• Supports maintenance of effective laboratory systems, incl. instruments and equipment to ensure integrity of all laboratory results.
• The QC Associate I/II will possess demonstrated technical ability regarding fundamental laboratory techniques and analytical methodology and/or EM and UM skills.

The position requires but is not limited to the following:

• Understanding of basic scientific principle
• Ability to communicate with peers and management
• Effective organizational skills
• Ability to multi-task and coordinate multiple activities in parallel
• Developing or demonstrated problem solving skills
• Developing or demonstrated instrument/method troubleshooting skills
• Good working knowledge of operations/quality systems
• Completes deliverables within targeted timeframes with good quality
• Able to draw conclusions from data interpretation
• May have technical writing skills, author’s reports with input & guidance and conducts compliance/work impact assessments as appropriate. Works on process improvements, actively supports management & QC teams.

Qualifications

Associate I:

• 0-2 years of relevant experience (B.S. degree)
• 8+ years of relevant experience (A.S. degree)

Associate II:

• 0-2 years of relevant experience (M.S. degree)
• 2-3 years of relevant experience (B.S. degree)
• 4 years of relevant experience (A.S. degree)

Additional Information

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