Quality Control Analyst II
The Quality Control Operations (QCO) Analyst II Contractor supports maintaining high standards of quality and compliance from development through commercialization. The role includes performing routine and non-routine testing, participating in data trending, investigations, and lab operations, and supporting method transfers, qualification/validation, verification, and implementation. This position enhances QC efficiency and effectiveness.
Key Responsibilities- Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies following SOPs
- Support weekend lab operations and maintain training records
- Assist in lab equipment and inventory maintenance, including reagent and sample prep Review data timely and qualify as a data reviewer
- Perform operational assignments (raw material processes, environmental monitoring, in-process testing)
- Contribute to updating controlled documents (SOPs, work instructions, test methods)
- Follow internal policies, SOPs, and regulatory standards (GMP, GLP, ICH)
- Participate in continuous improvement initiatives and cross-functional collaboration
- Support regulatory submissions, inspection readiness, and audits
- B.S. in chemistry, biology, biochemistry, or related field 4-8 years of pharmaceutical/biotech experience in GMP QC or equivalent
- Experience in method transfer/implementation; understanding of method lifecycle management preferred
- Strong technical writing, data analysis, problem-solving, and organizational skills
- Excellent communication and teamwork Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred
Recommended Jobs
Warehouse Worker
Job Title: Warehouse Worker MUST HAVE : shipping/receiving experience, FEDEX/UPS experience Responsibilities Handle shipping and receiving tasks effectively. Manage material handling proc…
Seasonal Part-Time Busser - 1606 Restaurant & Oyster Bar
Job Tracking ID: 512881-909019 Job Location: Gloucester, MA Job Level: Entry Level (less than 2 years) Level of Education: Any Job Type: Full-Time/Regular Date Updated: 03/10/2026 Year…
Medical Equipment Rep
Medical Sales Representative (Entry level or Exp.) We are a fast-growing specialty Medical Equipment distributor that markets a variety of innovative products. Our medical equipment products are de…
Healthcare Skills Training Instructor
POSITION: Healthcare Skills Training Instructor FLSA: Exempt Status: Full-Time REPORTS TO: Senior Healthcare Skills Instructor Position Summary: JVS’ Healthcare Skills Training prog…
ONCOLOGY NURSE NAVIGATOR
ONCOLOGY NURSE NAVIGATOR Job Ref: 33892 Category: Nursing Location: 133 Old Road to Nine Acre Corner, Concord, MA 01742 Department: Naka Infusion Center Schedule: Full Time Shift: Day…
Systems Engineer II, Digital Solutions Scientific R&D Labs
As a System Engineer at BioNTech, you will play a pivotal role in advancing the digitalization of our R&D labs by building, deploying, and maintaining innovative software solutions. Your work will …
Facilities Coordinator
Boston - Massachusetts - United States of America About The Role As a CBRE Facilities Coordinator, you will work with clients, vendors, and contractors to ensure that facility tasks and work or…
Landscape Maintenance Foreman
POSITION SUMMARY Egan Landscape Group offers competitive compensation, strong benefits, ongoing training, and opportunities for growth within a values-driven organization. The Landscape…
Senior Quality Assurance (QA) Engineer (Remote)
Remote (North America/Latin America timezones) No Agencies About Maximus Maximus () is a mission-driven consumer performance medicine telehealth company that provides men and women with cont…
Custodian, SMS 2pm-10pm
Job Description Job Description Duties for this position include general cleaning of classrooms and bathrooms, lifting, knowledge of floor management (stripping, waxing, buffing, mopping, etc). T…