QC Analyst or Senior Associate (3/12 Shift = Sat – Mon, 6 AM – 6 PM)
The Quality Control Analyst position requires a variety of skills necessary for biotech company operations. The successful candidate will independently perform routine and complex testing of process samples, raw materials, finished products and stability samples, while adhering to SOPs and working in a cGMP compliant environment. The QC Analyst will analyze and interpret results in both written and oral format regularly. Additionally, this position will support Preventative Maintenance and basic Laboratory maintenance activities while maintaining a GMP quality system. Other duties will include data review/archiving, database entry/review, training and mentorship of junior staff and contributions to process improvement initiatives. Technical procedures include LC/MS, HPLC (Size Exclusion, Reverse Phase, Ion Exchange), CE-SDS, SDS-PAGE, ELISAs to support the analysis of therapeutic proteins. This role will be involved in assay qualification/validations and routine sample analysis. II. Hours for this position will be 6 AM – 6 PM, Saturday to Monday (3/12 Shift). Qualified candidate will be hired at the appropriate level (Analyst or Senior Associate) to commensurate with education and years of required elevant experience.
Requirements:
The Role (daily responsibilities)
• Develop a plan and execute laboratory work, plan/schedule independently using customer milestones and business objectives.
• Author technical documents such as protocols, SOPs, reports and COAs.
• Perform parallel review of laboratory documentation, review technical documents for accuracy, thoroughness and regulatory compliance.
• Train, coach and mentor on technical issues, train others on laboratory techniques.
• Execute operational excellence/efficiency improvement projects with guidance.
• Identify and recommend business opportunities on a project basis.
• Other duties as assigned
The Candidate (requirements)
• Bachelors Degree w/ 7+ years experience OR Masters Degree w/ 4+ years experience OR PhD w/ no previous experience to qualify for the Analyst (salary, exempt) level. B.S./B.A. in Biotechnology, or related field, with minimum of 3 years experience in related laboratory work; or M.S./M.A. in Biotechnology, or related field, with no prior experience; or Associates Degree/Certificate/Diploma in laboratory science with minimum of 4 years experience in related laboratory work for the Senior Associate (hourly, non exempt) level.
• Experience with LC/MS is helpful
• Ability to maintain batch records and/or laboratory notebook and complete all laboratory documentation in clear and accurate language and according to SOP.
• Ability to attend training and apply learning on routine operation, maintenance and theory or laboratory instrumentation, SOPs, and regulatory guidelines.
• Ability to write SOPs, batch production records and reports independently.
• Ability to complete investigation, deviation, and change control forms independently.
• Ability to problem solve to initiate and execute/monitor corrective action.
• Proficient in operation and troubleshooting of a wide variety of instrumentation and data systems.
• Ability to work with other groups to develop, qualify and transfer methods accordingly.
• Understand and independently apply GMPs to everyday work with regard to documentation and instrument use.
• Understanding and adherence to applicable regulatory guidances.
• Demonstrates theoretical understanding of the work tasks assigned.
• Experience with HPLC, SDS-PAGE, cIEF, ELISA, Microbiology, pcr, and/or RT-PCR (as applicable) for the analysis of pharmaceuticals prefered
• Responsibilities for the drafting and revision of stability protocols per ICH guidance and Client requirements.
• Write Certificate of Analyses, Product Information Sheets and Stability final reports. Data archiving and maintenance.
• Write, edit and review Standard Operating Procedures (SOPs).
• Maintain lab equipment, including qualification and calibration.
• Ability to develop Proficiency with Trackwise (R) quality management software.
• Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines.
• Ability to use Excel, Word, and other office systems.
• Ability to add, subtract, multiply, divide and to record, balance, and check results for accuracy.
• Ability to formulate complex and comprehensive materials such as authoritative reports and/or to create/deliver formal and informal presentations.
• Ability to cross-train on techniques across multiple groups.
• Ability to peer review data to ensure data is well organized with complete documentation.
• Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions.
Position Benefits
•Potential for career growth within an expanding team
•Defined career path and annual performance review and feedback process
•Medical, Dental, Vision and 401K are all offered from Day One of employment
•19 days of paid time off annually + 7 paid holidays
About Catalent
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market, for the benefit of patients globally.
Catalent. More products. Better treatments. Reliably supplied.
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Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493 .
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
