Grifols Shared Services North America, Inc Quality Control Manager in Allschwil,
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.
QC Manager is required for a new purification plant for the blood protein albumin at Grifols Worldwide Operations (GWWO).
This role offers a chance to work in a state of the art facility, in an innovative Biotechnology company with excellent career development opportunities and a clear and committed patient focus.
Reporting directly to the Technical Director of Grifols Worldwide Operations (GWWO).
Oversee the daily activities in the QC Chemistry and the QC Microbiology to ensure that all cGMP, company specifications, procedures and guidelines are followed.
Review and approve batch records for Final Container and In-Process Intermediates.
Develop, improve and implement Quality Control systems throughout chemistry, methods development and Microbiology.
Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
Responsible for development of the QC Labs, including motivating in a manner that promotes the achievement of QC Lab’s business goals and objectives
Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training.
Manage the QC Lab's department's budget.
Provide hands-on guidance and training when needed. Appraise performance of department personnel, coach and counsel employees. Address complaints and resolve employee related problems with the collaboration of Human Resources.
Build organizational competency and succession plans.
Involvement in interviewing/selection process of hiring or promoting department personnel.
Conduct performance reviews of personnel.
Master’s degree in Chemistry, Biochemistry or closely related scientific field. Knowledge of Microbiology and Biology is advantage. An equivalent combination of education and experience may be taken into consideration.
Requires a minimum of 5 years of related experience. Project or technical leadership experience required. Supervisory or management experience preferred.
Knowledge, skills, abilities:
Ability to institute a wide array of Standard Operating Procedures and GMP-based projects and ensure laboratory personnel follows all SOPs.
Experience with investigating Out of Specification events, and writing thorough reports regarding the investigational findings.
Experience in statistical analysis. Strong knowledge of compendial issues and pharmacopoeias. General knowledge of pharmaceutical plasma-derivative company process, equipment and their microbiological control.
Interpret and apply applicable 21CFR, USP, EP and ICH regulatory guidelines and directives
Knowledge of and proficiency in the use of analytical instruments including troubleshooting skills. Strong knowledge of small molecule analytical technologies (e.g. GC, HPLC, AA, etc.). Strong knowledge of analytical techniques for biologics or protein-based therapeutics.
Excellent verbal and written communication. Must be able to read, write, and speak English. Must have strong technical writing skills. Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner. Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment. Strong organizational, analytical and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis.
Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home