Location: Buena, NJ
Responsible for maintaining laboratory operations, raw material sampling, sample coordination of raw materials, packaging components, bulk, finished product and stability samples.
Reporting Relationships: 4-6 direct reports
- Responsible for supervising both sterile and topical sampling areas to ensure compliance with approved SOP’s.
- Responsible for FDA and CFR raw material sample retains as well as Finished Product retains.
- Responsible for reviewing and approving all Raw Material Sampling Cards.
- Responsible for approving external testing lab allocations as well as the review of all external testing results.
- Responsible for the chain of custody of samples which includes raw materials, packaging, bulk, finished product, commercial stability and pre-approval stability.
- Responsible for overseeing, reviewing and approving all minimum fill and weight loss testing.
- Responsible for ordering all laboratory supplies. For example, glassware, reagents, reference standards, chromatographic columns, disposable testing supplies, PPE, notebooks, etc.
- Ensure compliance to good documentation practices within group.
- Responsible for hazardous and non-hazardous waste management within the quality control laboratory.
- Responsible for good housekeeping and glassware washing within the quality control laboratory.
- Work with manufacturing, packaging, CMOs, and quality assurance to manage receipt of laboratory samples.
- Oversight of sample distribution to respective testing departments.
- Write and revise routine laboratory SOPs as needed.
- Responsible for maintaining compliance to GMPs in all areas.
- Assist QC department members with tasks as needed, this may include input for the raw materials testing lab as well as the stability program.
- Keep Manager informed of all key quality findings and issues.
- Assume other activities and responsibilities from time to time as needed/directed.
- BS degree in a science related field and a minimum of 5 years of experience in Quality Control.
- Demonstrated ability to work on multiple projects and meet timelines
- Knowledge of cGMP requirements. Practical experience with document control, and QA support of manufacturing
- Strong knowledge of Microsoft Word and Acrobat (PDF) documentation systems.
- 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 in a fast-paced laboratory setting.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Good written and oral communication skills.
- Physical Demands
- Ability to lift
- Inside and outside work
- Move between buildings
- Temperature variations
- Sit and stand for long periods
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