K. STEPHAN GROEHNERT

201-***-**** / acv0bt@r.postjobfree.com / www.linkedin.com/in/Stevegroehnert

Professional Highlights:

** ***** ** ************** **********, 12 years in management

Manager QC Microbiology lab – Sterility, Swab, Bioburden, Water, MLT, Safety and Endotoxin (Pfizer)

Manager QA documentation – batch record revision, issuance and archive (Pfizer)

Lead investigator for QC Chemistry & Microbiology lab (Pfizer)

Manager QA auditors - chemistry & microbiology QC lab (Teva)

Auditor chemistry and biology raw data for QC release (Teva)

Analyst - raw material/finished product chemistry testing in QC and Investigator - QC, R&D (Barr Labs)

Detailed Experience:

Pfizer Biologics (formally Wyeth Biotech) Pearl River, NY (September 2002 - Present)

QC Manager Microbiology

Supervising over six analysts. Managing daily, weekly and monthly laboratory activities, such as monitoring of equipment, completion and review of equipment logbooks, managing the laboratory waste, checking/reviewing calibration of lab equipment, resolving discrepancies, performance and compensation management, training and hiring/terminating. Familiar with Controlled Environmental Areas, Environmental monitoring, (non-viable and viable, particulates, temperature, relative humidity, and room air pressure differentials) and manufacturing in a Grade A area.

Endotoxin testing (Gel Clot & Turbidmetric), Bioburden (pour plate & membrane filtration), Swab, MLT, General Safety, Media fills, TOC and Conductivity testing.

Site owner for all Chemistry & Microbiology water testing (e.g. WFI, Purified, Clean Steam, Potable). Issues water trend reports for each water system.

Manage Sterility Isolator testing performed in LaCalhene Barrier system (decontaminated via VHP)

Complete all investigations, Change Controls and commitments on time on a 7 day a week testing cycle.

Major contributor in Lean Labs and process improvements via cycle-time reduction, Hoshin, “Just Do It” and Kiazen initiatives.

Managed systems for clean steam generator, purified water, VHP generators and Isolators.

In charge of department’s autoclaves, representative on the site team for autoclaves and water monitoring.

Write and revise SOPs, approve Validation studies and PMOs, maintain team +95% trained and identify problems in LACES/LIMS for remediation.

Experienced in Change Controls, contract labs, commitments, CAPA and investigations.

Provide work assignments to direct reports on a regular basis. Review and approve the work performed by other analysts. Ensure work is done in a compliant manner according to SOPs and GMP guidelines.

Assisting with internal/external audits, as well as remediation from audits.

QA Manager

Oversaw QA Documentation.

Issuance and reconciliation of Master Batch Records and Production Batch Records.

Revision/reconciliation of controlled forms and permanent archival management.

Managed and improved the site library document archival system from a chaotic to a controlled process.

QC Lead Investigator (hired during a Consent Decree to remediate investigations)

Investigate testing anomalies/errors in the chemistry and microbiological laboratories.

Identify the root cause, take immediate corrective actions to prevent future re-occurrence.

Working cohesively with QA, Metrology, Validation, QA Stability, Change Control, etc. to achieve on time closure of investigations within 30 days.

Compile and approve investigations through the ‘Trackwise’ program. If necessary, facilitate inter departmental remediation, issue commitments, follow up on CAPAs.

K. STEPHAN GROEHNERT

201-***-**** / acv0bt@r.postjobfree.com / www.linkedin.com/in/Stevegroehnert

Teva Pharmaceutical Elmwood Park, NJ (April 1999 to August 2002)

Supervisor of QA Document Review Group

Oversaw 8 QA Laboratory Auditors in three separate locations for chemistry and microbiology QC laboratory work including validation, metrology, method transfer, special requests, finished products, and raw materials.

Streamlined group’s activities, improved compliance, maintained computerized tracking system.

QA Document Review Laboratory Auditor

Audited chemistry and biology data generated by the QC lab for accuracy, and SOP/FDA compliance

Barr Laboratories Pomona, NY (May 1993 to April 1999)

QC Laboratory Analyst

Worked in Quality Control Laboratory performing raw material and finished-product testing

Worked with proficiency on HPLC, GC (glass packed & capillary), Malvern Particle Sizer, Brinkman Titrator, UV/VIS, specific rotation, NIR and FTIR

Performed full monograph testing via USP and Barr monographs on numerous raw materials: OVIs, assay, impurities, particle size analysis, arsenic, TLC chromatography, ethanol residue, identification, heavy metals, titrations (manual & potentimetericly) and viscosity Trained analysts and assisting R&D in method transfer and method revision

Responsible for lab safety, disposal of organic solvent, solid toxic ad nontoxic lab waste

cGMP Investigator

Responsible for analyzing errors that occurred in the QC and R&D departments, document errors, findings and solutions for the review by the FDA and Barr Lab Management.

Microbiology Lab Technician

Held co-op position assisting in the microbiological department performing microbial water testing, media preparation and sterilization of biological waste.

Center Drugs Pharmacy Waldwick, NJ (1989 to 1993)

Pharmacist Technician

Prepared prescriptions, maintained records of allergies and interactions, controlled inventory

Education:

Attended vendor’s training for HPLC by WATERS, Endotoxin testing by Cape Cod Associates and Malvern Particle Sizer

Effective investigation writing, root cause analysis training, CAPA and Method I training

LACES/LIMS, GXPharma, Trackwise, Maximo, IsoTrain, SAP, EAMS, PLATEAU

Completed 10 hour OSHA overview course

Experienced in Turbochrom, Waters Millennium, Microsoft suite, Word, Excel, and Access

Courses in team building, effective communications, problem solving and technical writing

BS in Biology from Ramapo College, May 1994

Member of the Biology Club of Ramapo College 1989-93

College course in Costa Rica-study of the tropical rain forest May 1993

Interests and Activities:

Computers, chess, cycling and weight training

Member of the Boys Scouts 1978-1988

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