10 Quality Control Analyst Jobs in Lexington, MA
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SPECTRAFORCE is Hiring a Quality Control Analyst Near Lexington, MA
Job Title: QC Analyst II – Biochemistry
Duration: 06 Months
Location: Lexington, MA (02421)Job Summary/Operations InvolvementThe 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.
Product TestingSpecific Biochemistry Focus Areas:
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.
Duration: 06 Months
Location: Lexington, MA (02421)Job Summary/Operations InvolvementThe 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.
Product TestingSpecific Biochemistry Focus Areas:
- Techniques: SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280, etc.
- 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.
- 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.
- 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.
- 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.
- Excellent communication, interpersonal, and organizational skills.
- Ability to work well both independently and in a team environment.
- Ability to prioritize work and multitask.
- 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.
- 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: Immediate supervisor, other personnel in the section or group.
- External: Analytical Development, R&D, Quality Assurance, other Quality functions, Regulatory, Manufacturing, Facilities, and Engineering.
- 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.
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.
Job Summary
JOB TYPE
Full Time
SALARY
$90k-118k (estimate)
POST DATE
06/17/2024
EXPIRATION DATE
07/07/2024
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The job skills required for Quality Control Analyst include SOP, Quality Assurance, Biochemistry, Troubleshooting, Problem Solving, LIMS, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Control Analyst. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Control Analyst. Select any job title you are interested in and start to search job requirements.
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The following is the career advancement route for Quality Control Analyst positions, which can be used as a reference in future career path planning. As a Quality Control Analyst, it can be promoted into senior positions as a Construction Inspection Services Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Control Analyst. You can explore the career advancement for a Quality Control Analyst below and select your interested title to get hiring information.
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