Pace® Labs · 9 hours ago
Sr. Quality Control Analyst
Waltham, MA
Full-time
Onsite
Mid, Senior Level
$35/hr - $50/hr
3+ years expPace® Labs is committed to advancing health and safety in communities through scientific innovation. The Sr. Quality Control Analyst is responsible for overseeing comprehensive chemistry and biochemistry policies, providing analysis and guidance on materials and products, and developing formulations for clinical trials.
Executive Office
Responsibilities
Serves as a lead to staff to include providing work direction, guidance, and training
Overseeing or reviewing, completing, and processing comprehensive types of forms, documents, databases, and related materials and information
Provides complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing
Provides complex to specialized review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients
Provides training and guidance on analytical tests, methods, and instrumentation, as required
Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change
Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients
Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients
Develop validate and transfer analytical methods. Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, DD-PCR, among others
Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products
Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards
Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team
Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment
Qualification
Required
Bachelor's degree in chemistry/biochemistry, or a closely related field
Three to five (3-5) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience
Complex to specialized principles, practices, and techniques of chemistry/biochemistry and formulation development
Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures
Complex to specialized methods to resolve chemistry/biochemistry problems, questions, and concerns
Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations
Understanding of broad testing tools, equipment, and calibration
Computer applications and systems related to the work
Principles and practices to serving as an effective project team member
Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations
Correct business English, including spelling, grammar, and punctuation
Performing complex to specialized professional-level chemistry/biochemistry duties in a variety of assigned areas
Overseeing and administering broad and varied chemistry/biochemistry/formulation functions
Ability to operate and train others in analytical instruments and manufacturing equipment
Training others in policies and procedures related to the work
Serving as a team member and the development and management of projects
Operating in a both a team and individual contributor environment
Interpreting, applying, and explaining applicable laws, codes, and regulations
Preparing advanced to expert functionals reports, correspondence, and other written materials
Using initiative and independent judgment within established department guidelines
Using tact, discretion, and prudence in working with those contacted during the work
Performing effective oral presentations to large and small groups across functional peers and the department
Contributing effectively to the accomplishment of team or work unit goals, objectives and activities
Establishing and maintaining effective working relationships with various individuals contacted in the work
Preferred
Master's or PhD degree is strongly preferred
Benefits
Medical
Dental vision
401K retirement savings plan (100% vested immediately in the employer match)
Life
Disability and voluntary benefits
Paid time off for holiday, sick and vacation days
HSA
Wellness program
Flexible spending accounts
Tuition reimbursement
Employee Assistance program
Parental leave
Optional legal coverage
ID theft
Company
Pace® Labs
Pace® works with organizations of all types, providing the science to ensure our air, water, therapies, and more are safe for use.
1001-5000 employees
H1B Sponsorship
Pace® Labs has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Late StageCompany data provided by crunchbase