Quality Control Associate Analyst
The Quality Control Associate Analyst will be responsible for collecting and analyzing cleaning verification swab samples. The Quality Control Associate Analyst will report data as required by project contracts within the QC department.
The Role (daily responsibilities):
- The main activities will be to collect and analyze cleaning verification swab samples and report data as required by project contracts within the QC department. The data will be used for release of equipment for manufacturing and may be used for submission in Regulatory packages.
- Executes testing procedures for the identification and characterization of raw materials, stability and finished products. Techniques include, not limited to: HPLC, GC, Karl Fischer, particle size, trace metals, FT-IR and dissolution.
- Participates in the self-directed work team in prioritizing, scheduling and resource allocation in order to maintain efficient workflow to assure completion of schedules.
- Ensure QC information and documentation is properly archived, tracked, trended and analyzed as needed.
- Ensure that all activities are performed according to the local Quality System and SOP’s, as well as national and local regulations
- Demonstrate behaviors and positive attitudes in line with QC values.
- Participates in or leads investigations of laboratory deviations and investigations.
- Assist in the resolution of routine, and non-routine, technical problems.
- Authoring and review of SOP's and test methods.
- Participate in QC process improvement projects.
- To perform checking & verifying of peers analytical data in accordance with in-house SOPs.
- All other duties as assigned.
The Candidate (requirements):
- Associate’s Degree with 2+ years of related experience; OR Bachelor's Degree in Chemistry, Biology, or equivalent with 0-2 years of experience is required.
- Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and site SOPs
- Ability to learn and retain technical information
- Proactive to address work issues at the individual level
- Executes routine laboratory procedures and methods with high quality
- Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
- Mathematical and scientific reasoning ability
- Proficient in core techniques
- Ability to operate assigned laboratory equipment
- Strong attention to detail
- Excellent written and verbal communications skills
- Lead by example according to Catalent's values and culture
- Recognizes unmet needs within local team
- Ability to collaborate with peers
- Strategy is focused on personal time management and efficiency
- Well organized with ability to multitask
- Ability to work effectively under pressure to meet deadlines
- On an average 8 hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds
- Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently
- May require the use of a respirator
- Medical, Dental, Vision and 401K are all offered from day one of employment
- 19 days of paid time off annually
- Potential for career growth within an expanding team
- Defined career path and annual performance review and feedback process
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. ™
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 [Click Here to Email Your Resumé]. 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.