QC Associate

Yoh Life Sciences is hiring a QC Associate for our biopharmaceutical customer in Bristol, PA
. You will be responsible for performing multiple tasks within the Quality Control (QC) group in support of large- and small-molecule GMP manufacturing activities. Key functions include review, approval and execution of analytical method qualification/validation protocols and reports, routine support for raw material and product release and stability testing, and documentation/data review of GMP analytical testing results.

Duration: Temp to permanent

Location: Onsite Bristol, PA

Pay: $30-45/hr DOE and level

Schedule: M-F 8-5pm

• Provide critical QC technical review of analytical test methods and method qualification/validation protocols and reports.
• Lead the execution of analytical method qualification/validation protocols and author technically sound method qualification/validation reports.
• Perform in-process, release and stability testing via small molecule (GC, KF, etc.) and bioanalytical techniques (U/HPLC, CE-SDS, icIEF, etc.) to support internal bulk drug substance manufacturing and third‑party drug product processes.
• Lead laboratory investigations to determine root cause for OOS, OOT, atypical and invalid test results.
• Contribute to laboratory operations by performing regular instrument calibration and minor instrument maintenance.
• Lead the implementation of programs (e.g., evaluation/implementation of compendial testing).
• Support operational systems (e.g., equipment maintenance, reagent preparation, forms control, etc.).
• Communicate effectively with clients, line management, colleagues and staff; work effectively as part of a team in all aspects of executing responsibilities.

• B.S. in a scientific field with 5–7 years’ experience or Ph.D. with 3–5 years’ experience working in QC analytical laboratory supporting GMP manufacturing is required.
• Expertise with theoretical, practical and compliance aspects of GMP analytical testing used for release and stability testing of small and large molecule therapeutics including GC, U/HPLC, CE SDS, cIEF and ELISA, and familiarity with submission‑quality documentation of test results.
• Experience with analytical technical transfer and qualification/validation of analytical methods used for testing small and large molecule process intermediate, release and stability samples.
• Experience with authoring, reviewing and approving analytical test methods, qualification/validation protocols and reports and SOPs supporting QC laboratory operations.
• Strong technical writing, review and oral communication skills and proficiency with Microsoft Office software.
• Experience with analytical methods used in testing samples obtained through execution of the Environmental Monitoring program, including analysis of viable and non‑viable air and surface samples, bioburden and endotoxin is a plus.

Estimated Min Rate: $31.50

Estimated Max Rate: $45.00

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 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)
• Met Life 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…