Duane Stephens Email & Phone Number

Somerset, Nj, Us

Somerset, Nj, Us

Daily supervision of QA associates responsible with oversight of GMP analytical laboratories. This includes direction of daily activities as necessary, resolution of problems/issues with QA and internal and external clients. Prepare associate performance reviews for assigned associates. Provide performance reviews in both oral and written form to associates. Review and approve Deviation Reports and/or Laboratory Investigations. Participate in interview and hiring process of new associates. Train and mentor new associates. Lead or assist in client audits. Lead or assist in internal department or system audits. QA review and approval of validation documents (IQ/OQ/PQ/CC). Lead or assist in GMP training for Operations or QA. Duties and responsibilities of the related QA group associate job description. Laboratory Walk-Through Audits.

Somerset, Nj, Us

Note: Company change part of Catalent acquisition of Aptuit clinical trial supply business.Daily supervision of Packaging QA associates includes direction of daily activities as necessary, resolution of problems/issues with QA and internal and external clients. Prepare associate performance reviews for assigned associates. Provide performance reviews in both oral and written form to associates. Review and approve Deviation Reports and/or Packaging Investigations. Participate in interview and hiring process of new associates. Train and mentor new associates. Lead or assist in client audits. Lead or assist in internal department or system audits. QA review and approval of validation documents (IQ/OQ/PQ/CC). Lead or assist in GMP training for Operations or QA. Duties and responsibilities of the related QA group associate job description. Packaging Audits.

Verona, Vr, It

Same responsibilities as Catalent Feb 2012. Daily supervision of QA associates includes direction of daily activities as necessary, resolution of problems/issues with QA and internal and external clients.

Verona, Vr, It

Manage client QA audits—including scheduling, preparation, planning, hosting, touring, observation response and CAPA. Assist with regulatory inspections (FDA, 1/08, 3/10; MHRA, 12/07, 5/08, 12/08; DEA, 7/10). Author, Review, and Approve SOPs. Vendor auditing. Internal auditing.

Verona, Vr, It

Audit data for compliance with cGMP, cGLP, SOPs, and testing methods. Audit of on-site laboratories for compliance with Aptuit SOPs. Release of raw materials and active ingredients in QTRAC for use in manufacturing. Approval of instrument qualifications (IQ/OQ/PQ) and change controls. Approval of laboratory deviations.• Approval of raw material and finished product specifications

Durham, North Carolina, Us

Audit data for compliance with cGMP, cGLP, SOPs, and testing methods. Audit of on-site laboratories for compliance with Aptuit SOPs. Release of raw materials and active ingredients in QTRAC for use in manufacturing. Approval of instrument qualifications (IQ/OQ/PQ) and change controls. Approval of laboratory deviations.

Troy, Michigan, Us

Audit data for compliance with cGMP, cGLP, SOPs, and testing methods. Audit of on-site laboratories for compliance with Aptuit SOPs. Release of raw materials and active ingredients in QTRAC for use in manufacturing. Approval of instrument qualifications (IQ/OQ/PQ) and change controls. Approval of laboratory deviations.

Paris, France, Fr

Personnel management: annual review, compensation management, goal setting, coaching, counseling, work prioritization, and interviewing. Directed OOS/OOT (out-of-specification/out-of-trend) result investigations. Performed statistical data trending in support of OOS/OOT investigations. Performed laboratory investigations—including root cause investigations and CAPA. Prepared and analyzed samples to determine the potency, purity, uniformity, and identity of finished pharmaceutical products. Authored, reviewed, and approved SOPs, LIR (Laboratory Investigation Reports), training modules, instrument qualification protocols, and laboratory instrument operating instructions. Qualified to review and approve laboratory data. Trained staff ranging from small-groups to over one-hundred in size. Topics included were: cGMP (Good Manufacturing Practices) regulations, safety, SOPs, and company policies.

Paris, France, Fr

Chromatographic (HPLC, GC) analysis of commercial pharmaceuticals for release. Qualified as a peer-reviewer, cleaning validation swabbing/analysis, and approval of laboratory data within LIMS.

Study director on several projects for government and industrial clients. Responsibilities included: proposal writing, task assignment, client communication, budget monitoring, data review, and final report production. Led large government project in the production of micro-encapsulated cinnamaldehyde in support of toxicological studies. Led small industrial project in the production of micro-encapsulated insecticide in support of EPA registration. Attained a Secret level government security clearance. Member of Laboratory Spill Response Team—including SCBA and full-body PPE training.