Head Microbiology Quality Control Lab Resumes in US-California-Santa Barbara: See Resume

Head Microbiology Quality Control Lab Resume

Contact Candidate

Name:

See Resume

Location:

US-California-Santa Barbara

Experience:

10+ yrs

Willing to Relocate:

Willing to Travel:

Most Recent Job Title:

Head Microbiology Quality Control Lab

Personal Website:

Objective:

Full time position; Supervisor,Manager,Director
Quality Control, Quality Assurance and Validation
Manufacturing and Production, Product Development, Manufacturing Research, Documentation Specialist, Training
Approximate Salary Range:$90,000 - $115,000

Resume Text:

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oratory (MQCL) activities:
- Collected and performed microbiological limit testing (United States
Pharmacopoeia (USP), and European Pharmacopoeia (Ph.Eur.) on bulk
pharmaceutical chemicals and drug products
- Collected and tested purified water samples from the various USP and Ph.Eur.
Purified Water Loops used to manufacture or test drug products
- Collected and tested finished products
- Collected and tested environmental monitoring samples for evaluation of
manufacturing and cleaning processes
- Evaluated and identified all test results of raw materials, intermediates and
finished products
- Prepared standard and sample solutions
- Prepared the media used in the microbiological testing and performed
appropriate growth / promotion tests using USP and Ph.Eur. recommended
standard microbiological strains
- Maintained appropriate records
- Prepared samples for shipment to outside contract laboratory for
microbiological testing
- Coordinated microbiological tests with sub-contracted laboratories
- Coordinated and performed microbiological laboratory equipment calibration,
qualification and validation
· Developed departmental budget and monitored expenditures for microbiology quality assurance and quality control, including defining materials, equipment, and personnel needs
· Supervised development and implementation of standards, methods and procedures for microbiological inspecting, testing, and evaluating finished products
WELEDA AG
Department Manager, MQCL (continued)
· Developed and executed hiring plans, personnel hiring, training and performance reviews
· Provided guidance to employees and supervised the work group
· Developed, authored, reviewed, and approved laboratory operations, safety issues, qualification protocols, and standard operating procedures (SOP) pertinent to laboratory assays and procedures
· Directed MQCL staff and daily operations, including release and stability testing, in-process testing, MQCL inspections and audits, MQCL documentation, equipment maintenance and calibration, and MQCL laboratory design and maintenance
· Assured finished products conformed to government and company standards and satisfies GMP regulations
· Coordinated interdepartmental activities
· Specified, procured, and coordinated validation, calibration, and maintenance of laboratory equipment and instrumentation
· Managed GMP material control program, including MQCL materials management, labeling and storage, MQCL materials inventory and use, and materials lot control
· Developed, reviewed, and approved applicable laboratory procedures and corrective measures dealing with laboratory deviations, incidents, and formal investigations
· Coordinated documentation of laboratory deviations, incidents, and formal investigations
· Developed and maintained appropriate controls around protocols and procedures, control forms, investigations, laboratory reports, and other controlled documents as needed
· Supervised transfer of validated methods to routine use, and the participation of MQCL staff in support of validation of methods and equipment
· Established and directed MQCL control programs and GMP training programs
· Reviewed and approved reports and other documentation prepared by QA and QC for regulatory submissions/inspections
· Presented microbiological controls and applicable data, explained incidents, trends, and reports as needed, and represented specific Weleda company manufacturing, quality programs, and practices to German national GMP regulatory agencies
· Served in various roles in cross-functional teams including senior management and quality control/assurance personnel, production, process development, engineering operation services, and other key interfaces
· Maintained positive relationships and networks effectively across sites and organizations, Member of “Parental Drug Association, PDA”
· Led department-wide and participated in company-wide organizational development
· Conducted self audits, vendor audits, and external laboratory audits

WELEDA AG, Schwaebisch Gmuend, Germany
Department Manager,
Production, Sterile Dosage Forms, June 1987—April 2003
· Managed and supervised the manufacturing and packaging of aqueous sterile medicinal products, including aseptically processed and terminally sterilized small volume injection solutions (Parenteralia), aseptically processed eye drops and nasal sprays, and terminally sterilized oral medicines. This site is the Weleda AG Group’s primary manufacturing site for sterile medicines in the world.
· Developed and optimized department organizational structure and responsibilities and maintained department goals
· Planned, developed, and managed department budget and monitored expenditures including defining materials, equipment, and personnel needs
· Developed and executed hiring plans, personnel hiring, training, and performance reviews
· Developed, authored, reviewed, and approved SOPs in compliance with general industry practices, e.g., EU-GMPs Annex 1 and USA-cGMPs
· Assured Weleda corporate policies were followed
· Re-designed new construction, qualification, and validation of production area facilities, with emphasis on the design and implementation of four new cleanrooms (EU-GMP Annex 1 Class A, B, C, D, corresponding to FDA – Class 100 critical, Class 100, 10,000, and 100,000) for the aseptic manufacture of injection solutions, eye drops, aqueous oral forms and nasal sprays
· Reviewed and processed Batch Production Records, contributed to annual Product reviews
· Established specialized training programs for all personnel involved with aseptical manufacturing processes
· Developed, implemented, assessed, and established GMP training programs for all personnel in contact with product quality
· Developed, reviewed, approved, and maintained appropriate and specialized training and cross-training programs
· Initiated, developed, implemented, assessed and established the QA Environmental Monitoring (EM) System and the Qualification/Validation System for all critical processes and equipment involved in the manufacture of aqueous sterile medicines, establishing the basis for national and international QA and Qualification/Validation Departments at Weleda manufacturing sites world-wide
· Coordinated cross-functional teams (i.e. Quality Assurance, (QA)/Quality Control, (QC), Qualification/Validation, Research and Development, Regulatory Affairs, Project Management, Technical Engineering etc.) in completing and optimizing production activities
· Served in various roles in cross-functional teams including senior management and Quality Assurance personnel, Manufacturing, Process Development, Engineering Operation Services and other key interfaces
· Developed, implemented, and assessed solutions for complex problems
· Maintained production of sterile pharmaceutical products in full EU-GMP compliance and in operational safety through auditing and evaluations
WELEDA AG
Department Manager, PSDF (continued)
· Specified, procured, and coordinated validation, calibration, and maintenance of production equipment and instrumentation
· Developed, implemented, assessed, established, and maintained appropriate Production Planning Systems for sterile pharmaceutical products
· Evaluated and resolved problems during day-to-day operation
· Oversaw the setup of critical new manufacturing processes and equipment
· Practiced risk-based issue management techniques
· Assured compliance with corporate change control procedures
· Presented manufacturing and packaging facilities, procedures and documentation of aqueous sterile medicinal products, and represented specific Weleda company manufacturing, quality programs and practices to German national GMP regulatory agencies, Member of “Parental Drug Association, PDA”

WELEDA AG, Schwaebisch Gmuend, Germany
Assistant Production Manager,
Production, Sterile Dosage Forms, Feb 1985—May 1987
· Assisted in the management and supervision of production operations associated with the manufacture and packaging of aqueous sterile medicinal products, including aseptically processed and terminally sterilized small volume injection solutions, aseptically processed eye drops and terminally sterilized oral dosage forms
· Assisted in optimizing department organizational structure and responsibilities and maintaining department goals
· Organized own daily workload schedule and relevant resource requirements
· Ensured functional unit's compliance with GMP and all its related elements such as facilities, documentation (SOPs and validation protocols etc.), training, reports, and records
· Developed and authored complex, explicit SOPs for manufacturing operations in strict accordance with EU-GMPs Annex 1 and specific Weleda company manufacturing, quality programs and practices
· Reviewed and processed Batch Production Records, contributed to annual Product reviews
· Supervised equipment/component preparation, sterilization and sanitation of aseptic filling rooms
· Prepared intermediates, bulk and finished solutions, conducted in process controls, performed sterile filtration, critical small volume sterile fills, aseptic manipulation, and sterilization
· Ensured that manufactured batches contain the proper ingredients and quantities
· Maintained records and clean production areas to comply with regulatory requirements, good manufacturing practices, and standard operating procedures
· Assisted with in-process testing to make sure that batches met product specifications
WELEDA AG, Schwaebisch Gmuend, Germany
Assistant Production Manager, PSDF (continued)
· Operated with minimal supervision complex systems and equipment and optimized their use in manufacturing in accordance with defined goals
· Implemented production procedures to optimize manufacturing, packaging and distribution processes and comply with regulatory requirements
· Monitored processes and results and suggested methods to ensure process success
· Acted as troubleshooter for processing problems, brought unusual problems (i.e., potential deviations) to the attention of the supervisor
· Developed and implemented maintenance programs for production equipment
· Provided training to new personnel in specific aseptical techniques
· Participated in cross-functional teams (i.e. Quality Assurance, (QA)/Quality Control, (QC), Qualification/Validation, Research and Development, Regulatory Affairs, Project Management, Technical Engineering etc.) in completing and optimizing production activities
· Participated in the presentation of manufacturing and packaging facilities, procedures and documentation of aqueous sterile medicinal products to German national GMP regulatory agencies

Landesdenkmalamt (Baden-Württemberg State Monument Office), Archeological Excavations at Lake Constance and area, Neolithic settlements
Archeological Assistant, Nov 1983—Jan 1985
http://www.comp-archaeology.org/Hornstaad.htm
· Created a grid of each site, and drew and updated maps of unit profiles, stratum surfaces, features, and findings
· Dug and searched for artifacts made of stone, bone, wood, and other materials, placing them in bags and marking them to show where they were found
· Recorded the exact locations and conditions of artifacts uncovered in diggings, using drawings as necessary
· Described artifacts' physical properties or attributes, such as the materials from which artifacts were made, and their size, shape, function, and decoration
· Cleaned, restored, and preserved artifacts

Institute for Bacteriology und clinical Chemestry, Singen and
Clinical Microbiology Laboratory, Ulrich Brunner, MD, Konstanz
Clinical microbiology laboratory technologist Jan 1983—Nov 1983
· Made cultures of body fluid and tissue samples, to determine the presence of bacteria, fungi, parasites, or other microorganisms
· Isolated and cultivated bacteria or other micro-organisms in prescribed or standard inhibitory media, controlling factors, such as moisture, aeration, temperature, and nutrition

Clinical Microbiology, Singen and Konstanz
Clinical microbiology laboratory technologist (continued)
· Identified and classified bacteria and other microbial organisms by microscopic examination of physiological, morphological, and cultural characteristics
· Performed various bacteriological, mycological, mycobacteriological, and parasitological tests
· Prepared specimens for microbiological analysis and performed manual tests in accordance with detailed instructions
· Prepared specified and differential media for the microbiological analytical tests

University of Konstanz, Federal Republic of Germany
Faculty for Biology, Research Scientist, Molecular Biology, May 1978—Dec 1982, Laboratory of Prof. Dr. med. Ernesto Bade
· Conducted basic molecular biological experimental research - using the integration and replication processes of the Bacteriophage “Mu” as the premier biological system - to study the mechanism of genetic transposition and the biology of bacteriophage Mu
- Experimental findings published in Virology 1981 Mar;109(2):267-80.
Clayton R, Schumann W, Bade EG.
In vitro insertions and deletions in the G segment of phage mu DNA do not
abolish the inversion process.
www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6259810&dopt=Abstract
- Medical Subject Headings:
Bacteriophage mu/genetics, DNA Transposable Elements, Recombinant,
DNA, Viral, Escherichia coli/genetics, Mutation, Plasmids, Recombination,
Research Support, Non-U.S. Gov't
- Project was supported by grants from the Deutsche Forschungsgemeinschaft
DFG to Prof. Dr. E.G. Bade

Education
1972-1973 University of California at Los Angeles (UCLA), Major in Bacteriology
1973-1975 Georg August Universität in Goettingen, Vordiplom Biologie
(equiv. Bachelors Degree Biology, microbiology, zoology, chemistry,
physical chemistry)

1975-1978 Georg August Universität in Goettingen, Hauptdiplom Biologie
Diplom-Biologen-Hauptprüfung (equiv. Masters Degree in Microbiology, Major in Bacteriology, Biochemistry, and Organic Chemistry)
Master’s Dissertation: “Die Chemolithoautotrophie als übertragbare Eigenschaft bei neuisolierten Bacterien der Coryneform-Mycobacterium-Rhodococcus-Nocardia (CMN) Gruppe” (“Chemolithotrophy as a Transmittable Attribute in Newly Isolated Bacteria Strains of the Coryneform-Mycobacterium-Rhodococcus-Nocardia (CMN) Group”)

1978-1982 Universität Konstanz, Doctoral Program,
Dissertation Subject: Integration and Replication of the
Bacteriophage “Mu” (Mutator)

Personal Data
· US Citizen
· Fluent in German (written and spoken)
· Computer proficiency, including MS Word and MS Excel
· Ceramic Artist
· Musician

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