Grifols Shared Services North America, Inc Quality Operations Associate in Los Angeles, California
Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
ESSENTIAL DUTIES & RESPONSIBILITIES include the following. Other duties may be assigned.
Responsible for quality oversight of the final container inspection and packaging operations. For example, AQL (Acceptable Quality Limit) sampling and inspection of packaged final container product, packaging area release, quality verification of first print and last print samples, lot reconciliation, etc.
Perform Label Control duties, i.e. inventory count and issuance of labels and inserts for the packaging process.
Receive, store and inspect retention samples (includes intermediates and final container products).
Inspect and release finished product produced in Instituto Grifols.
Perform annual inventory of quarantine areas and quarterly inventory of label control areas.
Perform distribution release verification of intermediates and final container products.
Perform packaging work order review.
Perform various SAP transactions from the processes mentioned above.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.
REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Associate degree in Biology, Chemistry, Chemical Engineering or closely related scientific discipline is required. Bachelor's degree preferred.
Related experience in a pharmaceutical, GMP, or FDA regulated environment is preferred.
Requires a basic understanding of quality inspection and label control.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Must be proactive, results oriented, and have strong attention to detail.
Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Excellent verbal and written communication skills in the English language.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Specific experience with SAP is preferred.
Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
Ability to lift /move up to 50 pounds.
Ability to stand for extended periods - up to four (4) hours at a time.
Manual dexterity to perform all job functions.
Exposure to toxic/caustic chemicals and biological hazards.
Must have 20/20 vision, or correctable to 20/20 vision.
Must have color perception/discrimination for inspection and/or testing.
*This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Learn more about Grifols at http://www.grifols.com/es/web/international/home