•6-month contract with potential of extension

•

Pay:

$30-32/hr At MilliporeSigma, they are at the forefront of life sciences, working tirelessly to tackle the industry's toughest challenges. By collaborating with the global scientific community, they strive to enhance health access worldwide.

Their mission is clear:

to equip scientists and engineers with top-notch lab materials, technologies, and services, making research and biotech production simpler, faster, and more successful. With a dedication to shaping the future of drug development, they're with our customers every step of the way, pioneering tomorrow's possibilities.

Scope of Responsibility:

Impacts the results of the Quality Assurance (QA) team and influences a range of customer, operational, project activities of Operations teams. Solves problems of varying complexity independently by identifying and selecting solutions and by analyzing information.

Role:

The individual performs a variety of tasks within the Quality Assurance department with a focus on Quality Management system, Customer and Compliance. It includes conduct and/or review , and approval of deviations, Trend investigations, OOS, CAPA, Effectiveness checks, change controls, Client communication, leading/hosting client program (such as client audits, client quality agreements) leading/Supporting/hosting Regulatory audits, supplier management program (supplier audits, supplier quality agreements) and internal audits.

Essential Job Functions:

Act as the Subject Matter Expert for RCA Analyze and evaluate information captured through investigations, communicate findings and recommendations. Review and approve OOS, trend, critical-impact deviations and lower impact deviations. Review / approve applicable CAPA records Communicate effectively with internal stakeholders and external clients to represent quality and company. Train Quality Specialists and/or Operations teams on quality topics. Provide support for regulatory inspections. Act as Quality SME during regulatory inspections and customer audits for areas of expertise. May review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records. May review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis. May review and approve validation files for systems and assays. Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics. May perform risk assessment using various methodologies.

Education and Experience:

Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in science or technical area with 1 or more years' experience in Quality Assurance or related field within a GxP environment. Associate of Science (A.S.) degree in science or technical area with 4 or more years' experience in Quality Assurance or related field within a GxP or regulated field. In lieu of either B.S./B.A. or A.S., 8 or more years' experience in Quality Assurance or related field within a GxP or regulated field.

Competencies:

Acts ethically and ensures quality of own work and that of others. Open-minded, flexible and works with agility. Takes responsibility for ensuring that turnaround times are met. Works with cross-functional teams and builds networks within QA and Operations departments. Collaborates with various teams to identify and implement improvements. Willing to embrace and implement change on a global scale.

Knowledge and Skills:

Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity). Excellent communication and interpersonal skills. The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

Pay:

$30.00 - $32.00 per hour

Education:

Associate (Required)

Experience:

GxP:

1 year (Required) CAPA review: 1 year (Required) trackwise : 1 year (Preferred) Root cause analysis: 1 year (Required) Ability to

Commute:

Rockville, MD 20850 (Required)

Work Location:

In person