Quality Control Technical Services Analyst 4

B.S. in chemistry, biology, or biochemistry, or related scientific field; advanced degrees considered; • Pharmaceutical/Biotech industry experience with 8-12 years in a GMP Quality Control function or equivalent, relevant industry experience. • Support and sometimes lead investigations into analytical and product-related quality deviations, employing root cause analysis and implementing corrective and preventive actions (CAPAs) to mitigate risks and enhance quality.

Title:                  Quality Control Technical Services Analyst IV
Location:          Norton MA - Hybrid 
Duration:          12 months with Possible extension

Schedule & Work Environment
•    Monday–Friday, standard business hours.
•    No anticipated overtime or weekend work.
•    Hybrid schedule; Manager will confirm specific in-office days.

Interview Process
Round 1 - Interview with Manager
Round 2 - Three separate 30-minute interviews with members of the team.

Overview 
The Quality Control Technical Services (QCTS) Analyst IV plays a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. In addition to active participation in stability studies, data trending, and investigations, this position will provide technical specification support and will assist in facilitating method transfers and implementation. By ensuring these critical activities are executed with precision, the Analyst IV significantly contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions.

This position is hybrid role in Norton, MA with responsibility at both locations (Cambridge and Norton) as well as across Alnylam contract organizations. 

Key Responsibilities (including but not limited to):
•    Provide robust support in the justification of technical specifications for raw materials, intermediates, and finished products, ensuring they meet all quality and compliance requirements.
•    Facilitate the transfer and implementation of analytical methods from development to routine use within the QC laboratory, including method validation and training of laboratory personnel.
•    Assist in the execution and documentation of stability studies, contributing to product shelf-life determinations and ensuring compliance with regulatory requirements.
•    Engage in the collection, analysis, and trending of QC data to identify and address potential quality issues, using statistical tools to ensure continuous product quality monitoring.
•    Support and sometimes lead investigations into analytical and product-related quality deviations, employing root cause analysis and implementing corrective and preventive actions (CAPAs) to mitigate risks and enhance quality.
•    Review routine and non-routine QC testing, ensuring the reliability and accuracy of results according to policies, procedures, and regulations.
•    Assist in preparing and reviewing technical documentation for regulatory submissions and audits, ensuring accuracy and compliance with global regulatory standards.
•    Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
•    Actively represent Quality Control at cross-functional forums, including CMC meetings, ensuring QC perspectives and requirements are effectively communicated.
•    Collaborate with other organizational functions, including CMC Development, Manufacturing, Manufacturing Technical Services, Supply Chain, Regulatory, and Quality Assurance to ensure alignment with overall business goals.

Qualifications
•    B.S. in chemistry, biology, or biochemistry, or related scientific field; advanced degrees considered;
•    Pharmaceutical/Biotech industry experience with 8-12 years in a GMP Quality Control function or equivalent, relevant industry experience 
•    Experience in technical specification development, method transfer, and/or analytical method implementation
•    Proficient in data analysis and interpretation, with excellent attention to detail
•    Solid problem-solving skills and experience in conducting investigations and implementing CAPA
•    Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously 
•    Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment
•    Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred

Ideal Candidate Profile
Required / Key Experience
The ideal candidate will have approximately 5–8+ years of relevant experience and should not be entry-level or have only 1–2 years of experience.
Key technical experience includes:
•    Background in quality control / quality technical services.
•    Method development and method transfers.
•    Experience performing and/or overseeing BK activities (term to confirm).
•    Ability to generate and review data.
•    Experience validating data sets.
•    Experience managing and maintaining quality records.
•    Strong experience with HPLC/UPLC methods.
•    Laboratory experience and strong understanding of laboratory processes.
•    Experience supporting drug products.
•    Experience overseeing laboratory output rather than performing hands-on laboratory testing.
•    Alego experience (term to confirm) would be a significant plus.

Education
•    Bachelor's degree in Biology, Chemistry, or a related scientific field.
•    Open to candidates with advanced degrees, including Master's or PhD.
•    More experience is acceptable and not a concern

Technology / Tools
•    Microsoft Office
•    Excel, including formulas
•    PowerPoint and presentation development
•    Adobe

Role Responsibilities / Environment
•    The individual will oversee and support what is coming out of the laboratory rather than perform hands-on lab work.
•    Strong data review, quality documentation, and technical oversight skills will be important.
•    Candidate should be comfortable working with QC data, methods, and quality records in a regulated environment.

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Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.