Location: Buena, NJ
Responsible for Quality Control functions including, conducting microbiology testing of raw materials, stability samples and finished products, assisting in Document Control of Quality Control Documents and assisting with all Quality Unit needs as they pertain to quality system compliance.
- Responsible for the testing coordination and technical support of the microbiology portions of the Quality Control laboratory.
- Perform microbial method validations and testing of raw materials, bulk, finished products and aseptic packaging components.
- Endotoxin testing and method validations – preferred experience with kinetic turbidimetric method (EndoSafe MCS).
- Review raw data generated by the laboratory to ensure compliance to good documentation practices.
- Work with production and manufacturing to schedule QC support for tasks, such as equipment swabbing, and water testing, and any other coordination required.
- Creates and revise product specifications as needed for existing and new products.
- Assist in the investigation of OOS/OOT data as needed.
- Conducts and/or reviews critical investigations and creates high level reports as required.
- Compiles, analyzes, trends data and creates visual representations of data.
- Serves as mentor and SME to all microbiology personnel.
- Perform Risk assessment, aseptic technique evaluations.
- Prepares SOPs as required. Complete projects in a manner consistent with objectives.
- Maintains laboratory supplies and reagents inventory.
- Participates in the overtime and weekend schedule as required.
- Initiates Change Control items and participates in the change control process as needed.
- Create, collect, track/trend, and maintain testing data in the appropriate document.
- Identify raw materials, bulk and finished product disposition with appropriate labeling.
- Write and revise specifications; maintain QC files, methods and other laboratory documents as needed.
- Collect and prepare laboratory samples for shipping.
- Keep Manager informed of all key quality findings and issues.
- Assume other activities and responsibilities from time to time as directed.
- BS in Biology or related field and a minimum of 5 years of bench experience in Quality Control Microbiology laboratory.
- 1-2 years of leadership experience preferred.
- Sterile pharmaceutical experience preferred.
- Knowledge of cGMP requirements. Practical experience with document control, and QA support of manufacturing.
- Excellent organizational skills. Demonstrated ability to work on multiple projects and meet timelines. Detail oriented.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Good written and oral communication skills.
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs