QC Scientist

Yoh, A Day & Zimmermann Company; False Pass (AK); On-site; USD 4,959,000 - 5,235,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account

401K Retirement Savings Plan

Direct Deposit & weekly pay

Certification and training

Job summary

Yoh, a Day & Zimmermann company, is seeking a QC Scientist to test drug product and drug substance samples for release, stability, and in-process activities. The role requires solid wet-lab skills, cGMP knowledge, and experience with ELISA and cIEF assays.

You will prepare samples, maintain documentation, and support investigations and SOPs in a fast-paced GMP environment. Qualified candidates have a bachelor’s degree in a life science and at least two years’ lab experience, including

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology or Microbiology or science related field.
• Minimum 2 years of lab testing experience with cGMP knowledge.
• Biopharmaceutical testing experience required and willingness to learn various techniques.
• Experience with ELISA (protein A, HCP) and cIEF assays.
• Strong understanding of cGMP and compliance guidelines.

Responsibilities

• Perform and train others on physical testing of laboratory samples using various chemical and biochemical techniques.
• Prepare laboratory samples, standards and solutions for analysis.
• Manage sample lifecycle and associated documentation, both physical and electronic.
• Author and participate in laboratory investigations and SOP updates.
• Review and approve laboratory data and support instrument lifecycle, transfer and validation.
• Maintain 5S and routine equipment/glassware cleaning; support continuous improvement.

Skills

Scientific knowledge

Lab techniques

Documentation

cGMP understanding

Biopharmaceutical testing

Assays (ELISA, cIEF)

Systems experience

Data integrity awareness

Education

Bachelor's degree in Chemistry/Biochemistry/Biology/Microbiology

Tools

SAP/ERP

LES

WebStatistica

Empower

Hamilton

Analytical instrument software (SoftMax)

Job description

Job Description

QC Scientist will be responsible for testing drug product and drug substance samples for release, stability, and in-process.

Key Responsibilities

• Perform and train others on physical testing of laboratory samples (drug product, drug substance, in-process, etc) utilizing various chemical and biochemical techniques including Immunoassay and Separations.
• Prepare laboratory samples for analysis and prepares laboratory standards and solutions.
• Manage samples and associated documentation for duration of sample lifecycle, both physically and electronically.
• Author and participate in laboratory investigations.
• Author, review, and revise SOP’s and support Electronic Notebook template development (testing electronic lab notebook templates, author user requirement specifications, etc)
• Reviews and approves laboratory data.
• Performs routine departmental GMP activities (lab instrument calibrations, preventive maintenance, audits, work orders, etc)
• Support analytical and instrument lifecycle, technical transfer, and/or validation
• Laboratory upkeep, maintenance, and continuous improvement (5S, routine equipment/glassware cleaning, etc)

Knowledge/ Education / Experience Required

• Bachelor's degree in Chemistry, Biochemistry, Biology or Microbiology or science related field
• Foundational scientific knowledge and technical skills for working in the lab
• Minimum of 2 years of experience
• Experience with laboratory testing as well as a strong understanding of cGMPs and compliance are necessary to execute job functions.
• Biopharmaceutical testing experience is required, ability to learn various techniques and assays.
• Assays includes ELISA (protein A, HCP) and cIEF (iCE3, Maurice)
• Strong understanding of cGMPs and compliance.
• System experience preferred SAP/ERP, LES, LES-EM, Webstatistica, Empower, Hamilton (automated liquid handling), analytical instrument software (SoftMax, etc)
• Working knowledge of cGXP, ICH guidelines, FDA, USP/EP/JP and data integrity guidelines and regulations

Estimated Min Rate: $36.00

Estimated Max Rate: $38.00

What's In It for You?

We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.