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Quality Control Analyst I

The Quality Control Analyst’s main job responsibility is to manage the Quality Control In-Process department documents to ensure their accuracy, quality, and integrity. The candidate will organize, maintain, track and archive department documents and records while adhering to the BioMarin's document lifecycle procedures and in accordance with the records retention schedule. The QC Analyst may be required to develop new processes and improve upon the current system to allow retrieval of data records more effectively. Periodically, the QC analyst may be responsible for training employees on records management procedures and policies, which include documentation, retention, retrieval, destruction and disaster recovery. The candidate may also assist with audits of data record systems and perform administrative tasks as needed.

 

Additional daily duties will include sample receipt and accessioning, laboratory housekeeping and infrastructure maintenance responsibilities, reagent preparation and lab supply management. As well as general support of routine testing analytical method or equipment validation, assay method/procedure development, and/or conducting investigations.

 

If time permits the Quality Control Analyst may be trained to perform select microbiological, biochemical and chemical tests of in-process product, equipment, and manufacturing facilities. All microbiological and analytical tests are performed under cGMP guidelines.

 

Work assignments will vary by degree of complexity. Employee is expected to follow SOPs, make appropriate decisions in daily activities with minimal needs for intervention, and be able to recognize deviations from routine practices. Incumbent must accurately complete tasks on time to achieve lab goals, meanwhile limiting GMP / procedural errors.

 

Note: This position is scheduled for either day shift (0800 – 1700) or swing shift (1400 - 2300) and will possibly require at least one weekend day (exact shift is TBD with Sun-Thurs, Mon-Fri, and Tues-Sat each as possibilities).

Qualities:

Seeking a candidate who is self-directed and highly motivated, and has the ability to work either independently or collaboratively. The QC Analyst will frequently work in a fast-paced and deadline driven environment, so it is important to possess a consistent ability to maintain focus and carry out tasks in a timely and accurate manner. Candidates should be detail-oriented, dependable, and trustworthy because they come in contact with complex and sensitive documents.

 

The QC Analyst should have the ability to prioritize, manage time well, multitask, and troubleshoot. Strong interpersonal communication and customer service skills are also essential because his/her role will regularly initiate and field communication with internal and external business partners.

 

Must have excellent record keeping, written, and verbal skills.

 

Ability to perform most tasks without supervision.

 

Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices is a plus.

 

Able to lift up to 25lbs

 

Computer literacy is required, proficiency with Microsoft Word and Excel is essential.

 

Must have excellent record keeping, written and verbal skills.

 

Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.

Bachelor of Science in a Biological or Biochemical discipline, or equivalent, with 0-2 years of relevant laboratory experience.

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