Quality Control Manager
- Salt Lake City, UT
The Quality Manager manages, controls, and improves the analytical laboratories such that analysis is provided on time, to defined procedures and in compliance with Good Control Laboratory Practice.
A fantastic opportunity is available for a Quality Control Manager to join our Quality team.
Scope / Dimensions of Role
- The Quality Control Department comprises a single laboratory hosting both chemical and microbiological testing units.
- The laboratories support the manufacturing areas within the factory to ensure high levels of customer service are achieved and consistently maintained.
- This role operates in a fast paced environment where the analytical team are managed and developed to achieve company goals and objectives.
- This is a technical role which provides analytical information for regulatory submissions and changes to existing and new products.
- Continuously evaluates new testing methods and seeks out opportunities for building in and validating process analytical testing in the manufacturing areas.
- Works closely with the Ops Quality team on batch release if required.
Responsibilities / Accountabilities
- Overall lead time from completion of production to clearance is reported to Supply Management.
- Integral part in ensuring Customer Service level is routinely delivered.
- Ensure compliance to international standards of GcLP
- Manage systems for laboratory equipment , procedures, documentation and training
- Ensure NPD transfer and improvement projects managed to project deadlines
- Continually improves, modifies laboratory work practices and procedures to compliment a flexible factory
- Conducts internal and external quality audits as required
- Approves specifications for existing and new products
- Requires a Bachelor's degree in Chemistry or related field with a minimum of 8 years full-time chemical laboratory experience or an equivalent combination of education and experience
- Requires experience with HPLC and other scientific instrumentation
- Excellent organizational and communication skills with ability to work cross functionally
- SAP and/or other data systems experience a plus.
- Authoring SOPs and analytical methods; execution of analytical methods and protocols.
- Ideally experience in dietary supplements or pharmaceutical GMP/GLP
- Ability to work on own initiative in an accurate and reliable manner
- Ensuring efficient management of resource to match a very flexible production facility
- Maintain Compliance to GcLP in pressure situations
- Maintaining high levels of attention to detail while under customer service pressure, resolving issues within agreed lead-times.
- Communicating failures quickly and accurately particularly where there could be an impact on customer service.
- Prompting improvements from routine laboratory operations to drive performance in the laboratory.
- Ensuring that RB Quality (Business) Management system meets corporate and regulatory standards, while improving operational effectiveness. Failure could result in regulatory non-compliance with impact on customer service and routine business activity.
- Manages the laboratory in compliance with Health, Safety & Environmental procedures and regulations.
- To develop and improve the laboratory function to ensure compliance, efficiency, competency and understanding, using accepted business best practice in a fast moving health products environment.
- Use of electronic systems and records and best practice technology remaining fully compliant but continually improving effectiveness.
- To ensure documentation compliance and user friendliness within the laboratory environment
Is this You?
- Expected to have experience in a similar role in the pharmaceutical or an associated industry
- Good understanding of pharmaceutical quality systems
- Working knowledge of IT systems and their validation e.g. SAP LIMS, Empower, etc.
- Broad knowledge of pharmaceutical manufacturing processes including multiple dosage forms.
- Analytically capable, able to understand and resolve technical issues
- Microbiologically knowledgeable through experience or professional qualification
- Qualified Life Science professional - Degree, and member of professional body.
- Project management skills
- Able to manage a team of people
In return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly Global organisation.
Apply Now for a chance to really change the game!
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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