Perform testing of incoming materials and finished products for release in order to support Quality Systems objectives. Requires through knowledge of cGMP's and regulations applicable to the FDA and international regulatory agencies. Activities are performed in accordance with FDA Quality System Regulations and ISO standards. Candidate must be willing to work in a complex and fast paced environment, be a team player with effective verbal and written communication skills, and has well developed GMP documentation skills.
This position will provide weekend and day shift coverage.
Day Shift: 9:00 am - 6:00 pm
Work week: (SAT, SUN, MON, TUE, WED) or (WED, THUR, FRI, SAT, SUN)
- Perform hands-on laboratory testing activities related to raw material and product release testing.
- Perform data entry and analysis to support product testing according to established methods, while measuring results against specifications.
- Author and update product testing procedures and worksheets, as needed.
- Support studies for internal customers, which include validation and change control activities.
- Author laboratory investigations and product non-conformance reports.
- BS in Biochemistry, Molecular Cell Biology or similar field
- Minimum of 2 - 4 years of hands-on laboratory and/or manufacturing testing experience in a GMP environment is required.
- Knowledge of analytical chemistry techniques and protocols is highly preferred.
- Working knowledge of GMP, ISO, and QSR regulations highly preferred.
- Effective problem solving, troubleshooting and analytical skills.
- Ability to effectively work independently, with minimal guidance when performing routine testing.
- Effective organization and planning skills.
- Effective interpersonal skills, experience working in cross-functional teams.
- Fully effective written and verbal communication skills.
- Excellent computer skills with Excel and Word.
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