Accentuate Staffing is working with a client in the Raleigh area looking for a Microbiology Laboratory Manager. This person will direct the activities of and supervise a staff of 6-8 individuals that monitor the microbiological quality of products and production clean areas within the facility. They will develop, implement, and revise procedures to ensure compliance to current US and international Regulations. The ideal candidate will represent the site in all Regulatory inspections related to Microbiology and EM monitoring and report directly to the Site Quality Manager.

Responsibilities

1. Establish personnel, equipment, and supplies required for microbiological functions. Prepare appropriate justifications for fulfillment of these requirements.

2. Apply compendial and regulatory guidelines to laboratory test procedures. Present and defend data collected by these tests to FDA inspectors or European agencies as required.

3. Manage microbiological technical resources to determine conformance to product quality requirements.

4. Analyze and solve problems dealing with complex laboratory and production data to determine validity and reliability.

5. Analyze and disseminate microbiological data to indicate quality tends, and prepares a monthly report summarizing results to corporate.

6. Develop and administer expense and capital budgets to remain within spending constraints.

7. Provide microbiological expertise for problem solving and decision-making by plant management.

9. Represent microbiological assurance on continuous quality improvement teams

10. Responsible for approving all microbial OOS and OOT investigation.

11. Responsible for development of staff personnel, including mid-year/yearly evaluations, mentoring, and assuring staff remains current in all new microbial technological trends and Compendia requirements.

12. Responsible for development of all microbial protocols and defining validation requirements for microbial related validations.

13.Enforce EHS procedures and respond to EHS concerns within his/her area of operational responsibility.

14. Perform incident investigations and follow through regarding corrective actions.

Requirements

Bachelors degree in Microbiology, Biology or Science. Master degree is desirable.

Minimum 8 years in pharmaceutical industry; minimum 4 years

Knowledge of Industrial Microbiology; supervisory skills; oral and written communication skills

Thorough knowledge of cGMPs, FDA regulations, and USP/NF

Accentuate Staffing is currently recruiting for a Chemist to join our fast growing client in the RTP area.

Key technical skills required

Reverse Phase HPLC – Totalchrom acquisition software and predominantly Agilent HPLC systems

Experience with HPLC (any system) with Totalchrom would be a big plus

Aerosol Performance Testing (Metered dose inhaler experience preferred but not criteria for exclusion).

Dose Content Uniformity Testing

Aerodynamic Particle Sizing — Cascade Impaction, (Next Generation Impactor a plus however experience with other cascade impactors is fine)

Particle Sizing by Laser Diffraction — (Malvern Instruments a plus), experience with other instruments is fine

Spray Characterization, i.e. Spray Pattern & Plume geometry– (system used: Proveris SprayVIEW system), experience with other instruments is fine

Education

Bachelor’s degree and 2 years related experience

Accentuate Staffing is seeking an enthusiastic microbiologist for a long term contract with our client, a global vaccine company. This position will support the organization and start-up of the QC Microbiology laboratory. This individual will perform facility validation testing and routine EM and clean Utility testing. Qualified candidates must be open to working nights, weekends and overtime.

Additionally, this position will participate in the proper and timely execution of testing activities in the production areas and laboratories. Provide technical expertise and on the floor mentoring for gowning, disinfection and aseptic technique to manufacturing group.

Qualified candidates will have previous experience in two or more of the following activities:

Environmental Monitoring and Utility Monitoring programs

Perform bioburden, TOC, conductivity, pH, appearance, endotoxin testing for facility water as required

Perform sampling of site compressed gasses

Issue excursion notices and assist in investigating root causes.

Peer review data

Maintain GMP compliance and documentation

Maintain compliance with legal regulations on occupational safety and health, particularly with regard to hazardous materials.

Necessary Qualifications:

Intermediate knowledge of microbiology methods and instruments, as apply to aseptic processing. Including validation experience.

Knowledge of GMPs, safety regulations and data integrity

BA/BS degree in life science with 0 to 3 years directly related laboratory experience or equivalent education experience combination.

Accentuate Staffing is currently recruiting for a Physical/Occupational Therapist to join our client in Raleigh, NC.  This is a contract to hire opportunity with a growing organization that focuses on helping create safe work environments for organizations.

Job Description

Physical or Occupational Therapist, licensed in NC needed for Industrial Rehabilitation facility in Raleigh, NC. Therapist will conduct functional testing for new hires as well as injured workers and will have an opportunity to train and be certified in ergonomic assessments and job analysis. Experience in functional testing preferred, especially Functional Capacity Evaluations. We are not a treatment facility, so, if you are looking for something exciting and different from working in a traditional clinic, this is the place for you! There is tremendous opportunity for growth in this position.

Accentuate Staffing has an exciting direct hire opportunity with a parenteral drug manufacturing company here in RTP, NC. This position will be directly responsible for managing all sterile filling and sterilization activities on a 24 hour operation basis. Responsible for managing departmental personnel in a manner that ensures they are trained, qualified and at a skill level required for the jobs they perform. All operations are performed in classified pharmaceutical environments. Must be able to take a master schedule and create targeted filling and sterilization work schedules and ensure that all production requirements are met. The Superintendent will assure that manufacturing personnel adhere to operating procedures and processes, and that product quality is maintained at established standards and in full conformance with cGMP and all other regulatory requirements associated with domestic and international products. Incumbent is also required to maintain quality, safety, and ethical conduct while meeting production standards and schedules.

Essential Functions

1. Ensure that all quality standards are defined and met.

2. Ensure that all requirements are met for operations to be successfully conducted in ISO 5 and 7 classified areas.

3. Ensure production schedules are linked and necessary resources are utilized.

4. Review Standard Operating Procedures, revise as needed and ensure that they are current and comply with current Good Manufacturing Practices and any other regulatory requirements.

5. Direct personnel in safe work habits and maintain a safe work environment.

6. Advocate personnel development by setting objectives with subordinates and summarizing performance with annual reviews.

7. Develop and enhance reports utilizing statistical tools identifying and trending KPIs.

8. Write, coordinate and approve investigations on process variations and exceptions.

9. Provide support and assist the Validation Department in certifications and recertification.

10. Provide support and assist Operational Excellence Teams and Process Engineers by establishing project goals and implementing objectives.

11. Must be able to satisfactorily perform the essential functions of the Production Supervisor position to include Metric Stream, Compliance Wire, KRONOS and BPCS operation and reconciliation.

12. Must be able to fill in for the Production Manager position.

13. Periodically review work center staffing and routings, suggesting any changes as necessary.

14. Must master key critical job responsibilities of direct report(s).

Minimum Requirements

Education required: BA/BS degree in a Science or Chemical Engineering curriculum.

Experience: 5-10 years supervising/managing sterile filling operations.

Demonstrated leadership skills including oral/written communications, conflict resolution and decision making.

Preferred Skills/Qualifications: Sufficient financial acumen to interpret cost analyses and other reports. Demonstrate understanding of Six Sigma and Lean Manufacturing tools and concepts.

Skills/Competencies: Good PC proficiency.

Other Skills: Excellent organizational skills and ability to coordinate multiple projects. Must be able to create and enhance a team based environment.

Working Conditions

Work is performed in a pharmaceutical manufacturing facility under cGMP conditions for the filling of sterile and non-sterile liquids. The incumbent will oversee first, second and third shift operations. Operations extending over an entire 7 day work week are not uncommon; therefore, flexibility in work schedule is critical.

Please call Jeannelle at (919) 844-2900 X126 for immediate consideration!