- Perform microbiological assays for in-process and final product samples.
- Perform analytical methods for final bulk material/finished goods.
- Test and disposition of raw materials and perform environmental monitoring.
- Review of QC data for compliance to procedures and specifications.
- Calculate and evaluate results.
- Participate in lab maintenance and administration duties.
- Initiate lab investigations and deviations.
- Lab support including but not limited to glass washing, autoclaving, etc.
- Effectively demonstrate an understanding of CGMPs and how it applies to specific responsibilities.
- Follow accurate oral and written procedures for testing of in-process and final product samples.
- Provide input to the technical composition of operating documentation.
- Work independently under general supervision and direction.
- Work in compliance with cGMPs.
- Practice safe work habits and adheres to Vericel's safety procedures and guidelines.
- Maintain lab documentation and notebooks, ensuring timely review, reconciliation and filing.
- Other duties as assigned
- Understanding, observing, and adhering to the goals and policies outlined in Vericel's Code of Business Conduct and Ethics
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Bachelor's degree or equivalent education and experience. Biotechnology certification will also be considered.
- 1 year of experience in a CGMP lab environment.
- Proficient in Outlook, MS Word, Excel and lab based data management systems.
- Experience with microbiological testing or environmental monitoring
- Ability to lift 40 lbs.
- Requires working one day per weekend.
- Rotating holiday coverage
- Rotating off-shift remote alarm coverage
- May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
-
Quality Control Analyst
1 week ago
Actalent Norwood, United States Full timeDescription: · Run QC microbiology experiments. · Support EM, Bioburden, and Microbiology testing. · Run QC microbiology/bioassay testing. · Support CAPAs and Change Controls. · Support PCR, Sequencer, Pipette, Endotoxin or Sterility testing. · Additional Skills & Qualifications: ...
-
Quality Control Analyst
4 days ago
Eurofins USA PSS Insourcing Solutions Andover, United States**Company Description** · Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, t ...
-
Project Controls Cost Analyst
4 days ago
ENTRUST Solutions Group Marlborough, United States**As a Project Controls Cost Analyst, a typical day may include the following**: · - Assist in collecting project data, including budgets, schedules, and resource allocation · - Analyze project data to identify trends, variances, and potential risks · - Create and maintain projec ...
-
Temp to Perm-inventory Control Analyst
1 week ago
Hardware Specialty Co., Inc. Marlborough, United States**Temp to Perm** · **Position**: Inventory Control Analyst · **Reports to**: Inventory Control Supervisor · **Duties and Responsibilities**: · - Analyze Nine Month Residual Inventory report · - Approve and make changes to sales orders over $500.00 · - Analyze and process stock ro ...
-
Quality Control Analyst Iii, Microbiology
2 days ago
Lantheus Medical Imaging Inc Billerica, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. · ...
-
Vor Biopharma Inc. Cambridge, United StatesWho we are looking for: · Vor Bio is seeking an experienced Quality Control Senior Analyst to be a part of the team responsible for the day-to-day operations assigned to the QC Microbiology group, including sampling of a cGMP manufacturing facility, testing samples in the QC Micr ...
-
Manager of Building Inspections
3 days ago
City of Cambridge, MA Cambridge, United StatesPosting Date: · **5/13/24** · - Department: · **Inspectional Services Department** · - Job Code: · **M245** · - Sequence #: · **001** · - Number of Hours Per Week: · **37.5** · - Additional Work Hours Information: · **May be called upon to work during emergencies and after hours ...
-
Grants and Contract Financial Analyst
4 days ago
Boston Medical Center Boston, United States***: · The Grant Analyst is responsible all post-award financial functions for the assigned contract and grant portfolio. The Grant Analyst will work closely with the PI and program staff to ensure timely and applicable budget, expenditures and projections. The Analyst will colla ...
-
Boston Medical Center Boston, United States**Position**:Research Finance Analyst II, Finance Administration · **Location**:Boston, MA · **Schedule**:40 hours per week, **Hybrid** · **ABOUT BMC**: · At Boston Medical Center (BMC), our diverse staff works together for one goal — to provide exceptional and equitable care to ...
-
Project Manager
1 week ago
ILabz Technology Boston, United States**Role & Responsibilities**: · - Project Management leads the project team and various business units in defining scope, planning, budgeting, and controlling all project tasks, resources, and deliverables. · - Ensure that all project members adhere to strong project execution met ...
-
Liquidity & Market Risk Analyst
6 days ago
Santander US Boston, United StatesLiquidity & Market Risk Analyst · Boston, United States of America · The Liquidity & Market Risk Analyst calculates, analyzes and monitors the metrics obtained from risk systems. Reports the market risk metrics and positions in order to support the decision-making process of seni ...
-
Controller - Multi Location / Multi Account
1 week ago
Sodexo Boston, United StatesUnit Description: · **Your proven track record yields strong financial performance and sustainable initiatives. You're ready for the next challenge.** · - *Relocation Assistance Available*_ · **Sodexo's Campus Segment **has an opening for an experienced **Unit Controller Multi Ac ...
-
Contract Website Analyst
4 days ago
ALUMNI VENTURES SERVICES COMPANY LLC Boston, United States: · This is a contract position to assist with a project expected to last about 2 weeks, with a strong likelihood of ongoing work afterwards. · Hybrid or Remote but must be in the Boston, MA or Manchester, NH area. · **About Alumni Ventures** · Alumni Ventures (AV) is a leading v ...
-
Risk Coordinator
1 week ago
Off of the State Comptrollers Boston, United States**About the Office of the Comptroller** · The Office of the Comptroller ensures that the more than $50 billion in annual transactions authorized by the general appropriations act and supplemental appropriations are executed in accordance with all statutory requirements and record ...
-
Finance Regulatory Reporting, Vp
1 week ago
State Street Boston, United StatesWho we are looking for State Street is seeking a Business Analyst, Vice President in the Recovery and Resolution Planning (RRP) Office which organizationally sits within Global Treasury. The RRP Office is responsible for the US and international Recovery and Resolution plans, whi ...
-
Investment Operations Analyst
1 day ago
Global Atlantic Financial Group Boston, United States**COMPANY OVERVIEW** · Global Atlantic Financial Group is a leader in the U.S. life insurance and annuity industry, serving the needs of individuals and institutions. Global Atlantic is a wholly-owned subsidiary of KKR, a leading global investment firm that offers alternative ass ...
-
Meteorology Product Analyst
3 days ago
Claims Solutions Boston, United States**Company Description** · We help the world see new possibilities and inspire change for better tomorrows. Our analytic solutions bridge content, data, and analytics to help business, people, and society become stronger, more resilient, and sustainable. · Individual will contribu ...
-
Quality Assurance Reviewer Associate I
2 days ago
Commonwealth Care Alliance Boston, United States**Why This Role is Important to Us**: · **Position Summary**: · Reporting to the VP Quality & Controls Assurance, the incumbent is responsible for independent quality reviews of medical claims, and evaluating Call Center activities for compliance with policies and Standard Operat ...
-
inventory control analysts
1 week ago
BuildWitt Salem, United States**INVENTORY CONTROL ANALYSTS** · **** · Posted on: Jun 03, 2021 Location Salem, Pay Rate Based on qualifications. Location Salem, **Description** · Carter Machinery Company, the authorized Caterpillar dealer serving Virginia, West Virginia, Maryland, Delaware and Washington D. ...
-
Quality Control Analyst
6 days ago
Randstad Life Sciences US Norwood, United StatesTitle: Quality Control Bioassay Associate I · Location: Norwood, MA · Pay: $25-32/hr · Contract: 6+ months · Multiple Shifts Available · Job Summary · The Bioassay QC Analyst 1 will be responsible for GMP release testing of products produced at the GMP manufacturing facility and ...
Quality Control Analyst, I - Cambridge, United States - Vericel Corporation
Description
Job Description
Job DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Quality Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.POSITION SUMMARY
Department Description:
Quality Control (QC) is responsible for incoming inspection of components and raw materials, plus quality testing (e.g. analytical, microbiological) of intermediate, stability and final product samples to demonstrate that all products manufactured meet standards required for cGMP operations. Various techniques (e.g. assay transfers, validation and qualification of new instrumentation) are utilized within the Quality Control Laboratory to ensure cGMP compliance.
Position Summary:
Perform routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation.
DUTIES AND RESPONSIBILITIES
Essential Functions:
Leadership Responsibilities:
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Basic Qualifications:
Preferred Qualifications:
WORKING CONDITIONS AND PHYSICAL DEMANDS
EEO Statement
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.