P/T G/L & Payroll Accounting 

Consulting firm seeks an experienced accounting individual for their Hayward based company.  Perfect job for a parent that wants to work only during school hours:  Monday through Friday, 24 – 28 hours per week.  

Job responsibilities will include:  Month-End Closes, Payroll, Benefits Administration, weekly and monthly reporting.  Candidate must have experience performing general ledger reconciliations and preparing payroll.  A Bachelor of Science in accounting with at least 7 years of applicable experience is required.  The successful applicant will have outstanding communication skills (both written and verbal), excellent organization skills, the ability to multi-task and work under pressure while meeting defined deadlines, be detail oriented, a self-starter and a sincere team player.  An above-average working knowledge of QuickBooks Pro and Excel are a must.        

Senior Validation Engineer/Project Lead

We have an immediate need for this position initially located in Southern California, Nevada, or Florida. Responsible for scheduling and performing validation activities for a medical device process.

Must communicate daily with multi-department team to coordinate facility construction, manufacturing equipment move and installation. Ensure that the facility and equipment validation is completed on schedule.

Must understand process dynamics and their impact to schedule.

Must have thorough understanding of facility and utility validation.

• Experience developing validation master plans a plus
• Experience in medical device industry/validation a plus.

We are looking for an individual with the ability to learn new processes and programs. Must be able to work independently in a fast paced environment under stringent timelines.

Pharmatech Associates offers a commensurate salary and an outstanding benefits package for qualified employees.

The Project Controls Specialist will be responsible for managing all activities related to capital project cost control, as well as establishing cost management methods and procedures. Key activities will include but not be limited to:

• Track all project related cost and generated required reports for Project Managers and Department Management.
• Generate and track all capital project Purchase Orders/Contracts, to assure cost are properly allocated, both by vendor and project.
• Interface with accounting and purchasing as required to develop methods and procedures for cost tracking and reporting.
• Key role will be to interface with accounting to reconcile cost between capital project records and accounting’s to assure these cost are constantly align.
• Track and manage all activities related to invoicing to assure invoices are prepared properly and paid in a timely manner.
• Will be responsible for generating cash flows for projects, and then managing the invoicing process to assure planned cash flows are tracking with actual or take the required corrective action working the with the department manager.
• Play lead role in developing project budgets and then helping Project Managers / Management, manage to the budget.
• Manage the processing and tracking of change orders for completeness and accuracy.
• Lead the project cost estimating activities with Engineering Consultants and Construction Contracts (utilizing the estimating departments of the Engineering Consultants/Contractors).
• Prepare executive level presentation materials for department management and senior management that indicate project’s cost status and evaluate key project cost metrics.
• This shall include but not be limited to:
  • Overview level - project cost status sheets
  • Cash flow curves – actual vs. planned
  • Generate Earned Valve progress curves (as applicable)
  • Budget status by key line items - actual vs. planned
• Focus on cost trending – to predict any future project cost over-runs as early as possible.

COMPUTER Primavera Project Planner P3.1, P3 Pathfinder, Microsoft Project, Visio,

SKILLS MS Office Suite, Databases

QA Consulting

Position type: Full time
Required education: BA / BS
Area(s) of expertise desired: Minimum 5 years supervisory experience in Quality, GMP Manufacturing, & Supply Chain

Description
We are looking for a qualified candidate interested in Quality Assurance consulting. We have an immediate need for an individual to fill this need at one of client sites in their quality group. The scope of the Quality group's focus is to support the manufacturing and supply chain for solid dosage & capsule repackaging. The position is to develop, deploy and maintain a Quality System that assures compliance to FDA guidelines for GMPs. Work will include quality policy & SOP development & deployment; nonconforming material; deviation & CAPA development & execution; change control; assist in selecting appropriate software & developing compliant process flows for a fully automated ERP system; CoA's; assist in reviewing process flows developed around manufacturing operations; assist in reviewing process flows & documentation around labeling & traceability; assist in developing meaningful departmental performance/metrics; internal auditing; training; and analysis and resolution of customer complaints.

The successful candidate will be responsible to facilitate the required collaboration to operate the quality systems responsible for ensuring effective and compliant operation of review boards for nonconforming material, deviations, change control and support in regulatory filings. The QA consultant will provide a significant level of technical experience in support of investigations for the resolution of nonconforming material (DR's) and continuous improvement of policy and process.

The successful candidate shall possess strong leadership skills and decision making expertise. Preferred background shall primarily be in quality role in support of manufacturing (repackaging) and supply chain in a biotech and/or pharmaceutical environment.

Skills/Knowledge:
Extensive knowledge in system/process verification/validation.
Strong understanding of QSR and GMP as well as familiarity with 6-sigma and lean concepts preferred.

• Minimum 5 years supervision of quality in a manufacturing environment.
• Working knowledge of statistical and problem solving methodologies.
• Must have excellent computer skills, strong with MS office products.
• Knowledge of SAP ERP, filemaker pro, access, MS project, visio preferred.
• Excellent communication skills.
• Strong ability to lead, mentor and manage a team.

Consultants with the following background/expertise:

Analytical Method Validation

Bio/Pharma Operations (Minimum 3 years management experience)

Cleaning Validation

Process Methodology (Minimum 2 years experience. Prefer: SAP; EBR; lean manufacturing; six sigma; GMP integration).

Senior Process Methodology (Minimum 3 years experience in bio/pharma and 5 years experience in operations/process integration. Must be multidisciplinary. Following experience a plus: SAP; EBR; lean manufacturing; six sigma; GMP integration; life sciences; life cycle planning.)

Process Validation

Project Controls (Minimum 2 years experience. Prefer bio/pharma and P3 experience.)

Scheduler (Minimum 3 years experience. Prefer bio/pharma and operations planning.)

Validation Engineering (Minimum 2 years experience ranging from utility and facility qualification to solid dosage and packaging equipment qualification.)