Quality Control Analyst

SeraCare - Milford, MA (30+ days ago)4.0


SeraCare develops and manufactures controls and reference materials and related products for in vitro diagnostics. We focus on infectious disease, oncology, inherited diseases and maternal fetal medicine. SeraCare is the best in the world at developing and manufacturing disease mimetics which are biosynthetic or engineered versions of human disease material. We partner with IVD researchers, manufacturers and clinical laboratories to bridge the gap between today’s diagnostic solutions and tomorrow’s emerging technologies for molecular diagnostics, next generation sequencing and companion diagnostics. With more than 25 years of diagnostic industry experience, SeraCare is uniquely positioned to ensure the highest level of consistency, confidence and compliance as we jointly shape the future of medical diagnostics.

ROLE MISSION: Contribute to a highly motivated and cohesive internal QC testing team that functions to support manufacturing with timely and accurate in-process and final product testing. Support various internal teams by characterizing biological materials.

EXPERIENCE REQUIRED:
Bachelor’s degree in science or related field, Medical Technologist or Clinical Science degree preferred.

Must be a positive team player with excellent interpersonal skills. Must be skilled in performing ELISA’s.

Must have minimum of 2 years’ experience in a regulated laboratory facility with an understanding of immunoassays required.

Proven experience and ability to work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

Previous experience with a Roche c311 chemistry analyzer or other chemistry analyzers desirable.

Must apply company policies and procedures to resolve a variety of issues.

Demonstrated knowledge of personal computer software in a business environment. Microsoft Office preferred.

Must be able to work overtime as required. Ability and willingness to lift up to 30 pounds.

RESPONSIBILITIES:
Accurately perform ELISA, immunoassays, bioburden, Western Blot and other tests on infectious and non-infectious raw material samples and finished biological products.

Analyze, interpret, and record testing data with a focus on accuracy with the awareness that timely work impacts other groups to meet critical customer deadlines.

Maintain a high quality of work that has the potential to impact valuable product results, which are critical to customers.

TALENT/COMPETENCIES:
Excellent attention to detail and high standards for data quality will set you apart.

Strong team player who proactively communicates within teams and takes a ‘company-first’ attitude
Action oriented, able to take initiative where required without being asked

ATTRIBUTES:
Excellent verbal and written communication skills are essential, including the ability to communicate technical problems in a clear, concise manner.

Highly organized and process driven individual able to use multiple systems to achieve results

Continuous learner, always seeking opportunities to improve effectiveness of processes and tactics

Resilient and dedicated attitude that will do whatever it takes to meet and exceed goals

Flexible—able to work effectively in a variety of environments and situations

BENEFITS: The position is full-time, with competitive pay, excellent benefits including medical, dental & vision, generous Paid Time Off (PTO), Life Insurance, STD/LTD and a 401(k) plan with a match. SeraCare Life Sciences, Inc. is an Equal Opportunity Employer, M/F/D/V