Scientist I, Quality Control (Qc)

Job Title: Scientist I, Quality Control (QC)

Position Type: 12-month contract to hire

Location: onsite Rockville, MD

Salary Range / Rate (Currency): $32-$37/hr

Job ID#: 136774

Job Summary (Responsibilities and Requirements):

The Scientist, QC position supports the Quality Control group at the Rockville GMP facility for IND and Phase I/II GMP manufacturing. The role requires knowledge and experience of scientific concepts, practices, and procedures within the biopharmaceutical field and a cGMP environment. The QC Scientist will focus on supporting the routine operation of the GMP facility in analytical development, batch release, and stability studies, etc.

Responsibilities and Duties:

• Perform analytical testing applied by the QC Laboratory for evaluation of raw materials, components, and products at various stages of the manufacturing process following established ATMs or SOPs.
• Participate in activities as defined in method transfer/qualification/validation/stability study protocols.
• Review, analyze, interpret, and report data following GDP and ALCOA principles.
• Report and participate in investigations of deviation, OOS/OOT results, CAPA and other related activities.
• Author, review, and revise SOPs and ATMs, as necessary.
• Calibrate, validate, or maintain laboratory equipment when needed.
• Review and maintain laboratory data (including contract laboratories) to ensure accuracy and regulatory compliance.
• Perform other duties that may be assigned.

Qualifications and Requirements:

• Scientist I: Bachelor of Science (MS preferred) in a Life Sciences discipline with 1-3 years of relevant experience working in a Quality Control work environment, preferably in the pharmaceutical industry with knowledge of cGMP is a plus
• Considerable expertise relevant to QC analytical methods used for cell therapy manufacturing including qPCR/dPCR, ELISA, flow cytometry or cell-based assays in a GMP environment.
• Experience in technical writing skills in SOPs and analytical test methods as well as method qualification/validation documentation.
• Excellent written/oral communication and interpersonal skills

Preferred Qualifications:

• Self-starter with superior analysis and problem-solving skills ranging from simple to sophisticated situations.
• Be proficient in MS Office suite.
• Demonstrates proficiency in current Good Manufacturing Practice (GMP).
• Possess good communication skills to explain information and influence others
• Must have a strong work ethic and demonstrate dependability and timeliness.
• Have a high energy level and a positive outlook coupled with the requisite “can do” attitude.

About Us:

Founded in 2009, IntelliPro stands as a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. With a dynamic presence in the USA, China, Canada, Singapore, Philippines, UK, India, Netherlands, and Germany, we continue to lead the way in global talent solutions.

IntelliPro, a global leader in connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at https://intelliprogroup.com/.

Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility.

Job Type: Contract

Pay: $32.00 - $37.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Ability to Relocate:

• Rockville, MD: Relocate before starting work (Required)

Work Location: In person