Job Title: QC Analyst II – Biochemistry Duration: 06+ Months Location: Lexington, MA (02421)
Job Summary/Operations Involvement: The QC Analyst II – Biochemistry will primarily focus on daily lab operations and execution of testing to support manufacturing operations, validation, or development studies. Testing may include, but is not limited to, samples from drug substance and drug product manufacturing, stability, and various protocol studies using approved test methods or methods derived from QC technical protocols. The role may also involve sampling activities, maintaining operational and GMP readiness of the QC areas, and managing critical reagent inventory such as antibodies and cell banks. The individual may participate in complex projects, operational excellence initiatives, and various quality systems under general supervision. Specific Biochemistry Focus Areas: Product Testing:
Support for in-process, release, and stability testing.
Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation.
Introduction of new equipment and technology to improve sustainability and compliance.
Support for Quality projects and implementation of operational excellence initiatives.
Job Scope:
Objective-based assignments: Receives assignments in the form of objectives and establishes goals to meet these objectives. Work is reviewed and measured based on meeting objectives and schedules.
Policy recommendations: Establishes and recommends changes to policies that affect subordinate organizations.
% of Time and Job Functions:
40-50%: Testing execution, training analysts, troubleshooting methods.
20-30%: QC operations support (data review, data trending, OE/5S/LEAN initiatives, equipment and reagent maintenance, lab housekeeping, support for other QC groups, compliance, and quality systems such as SOP revisions and input to quality systems records).
10-20%: Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support.
Education and Experience Requirements:
Educational Requirements: Typically requires a bachelor’s degree in a science-related field.
Experience: Minimum of 5+ years of related experience.
Preferred: Previous experience in a GMP QC role.
Additional Specific Experience:
Excellent communication, interpersonal, and organizational skills.
Ability to work well both independently and in a team environment.
Ability to prioritize work and multitask.
Key Skills, Abilities, and Competencies:
Knowledge: Complete understanding and application of principles, concepts, practices, and standards in the field. Full knowledge of industry practices. Requires critical thinking.
Key Skills: Proficiency in MS Office, LIMS, SAP, Trackwise, compliance, and strong scientific understanding.
Complexity and Problem Solving:
Develops solutions to a variety of complex problems, often referring to established precedents and policies.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Networks with senior internal and external personnel in own area of expertise.
Internal and External Contacts:
Internal: Immediate supervisor, other personnel in the section or group.
External: Analytical Development, R&D, Quality Assurance, other Quality functions, Regulatory, Manufacturing, Facilities, and Engineering.
Other Job Requirements:
Travel: Limited to no travel expected, but travel between sites is required.
Physical Abilities:
Repetitive bending and reaching to set up and break down equipment.
Ability to work around chemicals in laboratory settings.
Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection.
Ability to walk and stand for periods of time.
Participation in environmental chamber monitoring program, including use of an on-call mobile phone and on-site support during non-business hours.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $50.00/hr.
