Sr. QC Analyst
Billerica, Massachusetts
- Full Time
- Level: Entry
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Overview
You’re the one who will help us meet and exceed the quality standards that medical professionals and patients expect from us. Collaborating with like-minded, inventive colleagues, you’ll take a balanced approach, tackling challenges, learning from mistakes, and creating solutions that empower our fast-growing company. Join a workplace that’s big on open communication and fueling your career growth. When can you start?
Success Profile
What makes a great Sr. QC Analyst at Sun Pharma? Take a look and see how you match up.
- Collaborative
- Communicator
- Detail-oriented
- Independent
- Problem-solver
- Team player
Our Culture
Discover an environment that’s open and transparent. Every day is a new opportunity to learn and grow, surrounded by powerful reminders of the impact your role has on patients’ lives. This is the Sun Pharma way of life. And we can’t wait for you to be a part of it.
Benefits
We’re in your corner – in so many different ways. Sun Pharma wants you to have the benefits, support, and rewards of a job well done.
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Career Growth
Get support for your career growth and development.
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Benefits Programs
Discover comprehensive benefits to support the health and wellness of you and your family.
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Time Off
Enjoy paid time off and leave-of-absence options.
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Compensation
Earn competitive compensation with incentive programs that reward our shared success.
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Working Conditions
Work confidently in the safe, clean, and regulated work environment that we foster.
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Team Environment
Collaborate in a workplace that’s rooted in our values and encourages cross-team engagement.
Sr. QC Analyst
Billerica, MassachusettsJob Summary:
Performs GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology. Monitors and evaluates systems, equipment, records and trends data. Reviews and revises documentation (i.e. SOPs). Works under limited supervision following established procedures.
Areas of Responsibility:
Perform release, stability, validation, analytical quality control tests and assays on raw materials, in-processing and final products following GLPs
Perform quality control tests and assays including USP test methods and EP test methods
Conduct, document and follow up on assay issues, failures and complaint investigations (Trackwise)
Calibrate, monitor, maintain and evaluate systems and equipment (i.e. water systems, environmental chambers, analytical instrument/equipment)
Maintain data in manual or computer based logs following GDPs
Develop, author, and execute instrument IQ/OQ and PQ protocols
Maintain major laboratory programs (i.e. calibration program, reference standard program)
Serve as liaison to service, calibration and technical representatives
Send samples to contract laboratories and collect test data
Wash glassware, prepare reagents, solutions, equipment for chemical tests and assays
Maintain laboratory in cGMP compliance and conduct internal lab inspections
Record and review GMP data, monitor and evaluate QC systems and equipment, recommend improvements to procedures, and revise GMP documentation as required
Serve as a leader within the QC group and a knowledge resource within the company
Provide mentoring and training to junior analysts on laboratory tests, skills, and lab processes
Perform monthly equipment/instrument maintenance and cleaning
Follow work-flow procedures from receiving test samples, monitoring inventories, to waste disposal
Train towards Visual Inspection qualifications
Other duties as assigned
Job Qualifications and Experience:
B.S. or equivalent experience
Excellent oral and written and interpersonal communication skills
Fundamental knowledge of chemical principles and analytical instrumentation
Ability to follow specific instruction (i.e. written SOPs)
Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
Proficient knowledge of basic and complex laboratory instrumentation (theory, function, basic and complex troubleshooting)
Strong analytical skills with attention to detail
Able to troubleshoot and repair complex instrumentation
Proficient computer skills including word processing, spreadsheet, and instrumentation control software programs
Able to perform standard and non-standard analytical techniques to analyze product
Proficient in use of Balances, Ultraviolet/Visible (UV/VIS) Spectrometer, Conductivity Meter, TOC Meter, pH Meter, Autotitrator, Karl Fischer Titrator, High temperature furnaces and oven, Fume hoods, Stirrer/hot plates, Propane burners, Compressed Gas Regulators and Cylinders, Melting Point, Infrared (IR), Gamma Ray Spectrometer and RCP assays, Flame Atomic Absorption (AA), Polarograph, Osmometer, High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC)
Minimum 5-7 years of related experience
Use of Trackwise, Novatech, and Empower software
Experience with qualitative and quantitative analysis using good analytical laboratory practices
Working knowledge of cGMP/GLP
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