Senior QA Associate
4 weeks ago
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community that's focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
Main Tasks and Responsibilities
- Provide QA floor support and oversight to the production of registration batches for clinical and commercial product materials to ensure that product is manufactured in accordance with specifications, customer's market authorizations and GMP requirements. Conducts floor audits and periodic checks of in process documentation and logbooks for compliance during second shift.
- Provide guidance to manufacturing and laboratory personnel to proactively ensure GMP compliance.
- Ensures timely initiation of deviations when quality issues are identified.
- Perform room and equipment releases and line clearance activities in support of on-time manufacturing.
- Review and release raw materials and components for dispensing to be used in manufacturing.
- Review and approval of the executed cleaning validation/verification reports.
- Review and issue product labels for use in manufacturing.
- Participate in investigations related to deviations, out-of-specifications or atypical results, and customer complaints. Identify and implement corrective and preventive actions that mitigate potential for issue recurrence.
- Communicate quality-related information and data to key stakeholders within and outside of QA.
- Engage on manufacturing meetings and assure appropriate assignments of quality activities.
- Perform other duties as assigned, and may need to adjust the timing based on the manufacturing schedule.
- While performing the duties of this job, the employee is frequently required to stand and walk
- The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl.
- The employee must occasionally lift and/or move up to 10 pounds.
- Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
- Must be able to qualify for respiratory protective equipment use.
- Associate degree in a scientific field, or equivalent experience
- Minimum three (3) years' related experience in QA or QC in life sciences
- Good understanding of CGMP requirements
- Good organization and time management skills
- Effective written and oral communication skills
- Good interpersonal skills with a special focus on customer satisfaction
When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
Other details
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