Quality Assurance Specialist

GrifolsLos Angeles, US , CA

12 days ago

Job type

Full-time

Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Job Summary :

The primary responsibility of the Quality Assurance (QA) Specialist is to work with a number of Quality Systems ensuring compliance is maintained to meet the current Regulatory requirements. The Quality Systems are Deviation Management, Non-Conforming Materials, CAPA, and Customer Complaints. The QA Specialist is responsible for product quality by evaluating various processes against validated methods and licensed parameters, while ensuring timely product release. Will interface with multiple departments to ensure successful results. The position will support regulatory reporting and communications as required. Other responsibilities will include individual and group projects to support Quality Assurance initiatives across the company.

Essential Job Duties :

Investigate and report as required, issues identified under the deviation management system including database management.
Focus on thorough investigations, sound root causes, meaningful corrective actions and identify areas where deviation reoccurrence could be avoided.
Work with various departments in the development of effective corrective and preventative actions. Follow up for effectiveness evaluation and database management.
Investigate and report on customer complaints and administer the customer complaint database. Interface with various departments to investigate and ensure timely resolution of complaints. Report both to the investigation file and to the customer.
Responsible for timely completion of the quarterly product review and other periodic reports as required.
Coordinate and manage investigations relating to trend analysis or problem areas requiring investigation utilizing multiple resources.
Assist in the closure of Out of Tolerance events, processing of Facilities Change Requests and the review of Documentation Change Requests.
Perform housekeeping inspections of manufacturing areas, report issues to area management, and ensure closure of all inspection findings.
Support regulatory submissions and responses as required.
Provide scientific and / or technical advice and counsel regarding projects as needed.
Participate in departmental and cross functional team meetings and / or assemble cross functional teams and / or facilitate team meetings as necessary.
Maintain current knowledge of regulatory and industry standards.
Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
Participate in regulatory and internal inspections / audits including providing written responses as applicable for area of responsibility.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.

Job Requirements :

Bachelor’s degree in Biology, Chemistry, Microbiology, Biochemistry or closely related scientific / technical discipline is required.

Minimum of 2 years of experience in a pharmaceutical, GMP, or FDA regulated environment is required. Direct experience in Quality Assurance, Quality Operations, Quality Control or Quality Engineering function is preferred.

Requires a basic understanding of pharmaceutical manufacturing, aseptic processing, laboratory processes and Quality Assurance / Operations. Knowledge or background in Quality systems and theory is preferred.

Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.

Experience in conducting investigations is preferred.

Must have strong technical writing skills.

Ability to work independently with minimum supervision.

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)

Occupational Demands Form : Work is performed in an office and a laboratory / manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32

in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception / discrimination and near vision correctable in one eye to 20 / 30 and to 20 / 100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions / procedures.

The estimated pay scale for the Quality Assurance Specialist role based in Los Angeles, CA, is $75,800 - $96,000 per year. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to : Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time.

Third Party Agency and Recruiter Notice :

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse / family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Location : NORTH AMERICA : USA : CA-Los Angeles : USVALLEY - Valley Bl Mfg Plant - LA, CA

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Quality Assurance Specialist • Los Angeles, US , CA