Document Control Associate Jobs in Wilmington, NC

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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The Scientist II - QC Chemistry is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist II QC Chemistry position, HPLC, dissolution, UV, osmolality, density, and pH are commonly employed in the described testing in addition to other key methodologies such as KF and titration. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company) and may also assist with method development / method validation projects.

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:30am - 5:30pm.

• Performs one or more of the following techniques: assays, potencies, pH, dissolution, moisture content, identification, particle size, and various other wet chemistry and instrument-based measurements.
• Evaluates and interprets generated data.
• Analyzes information for technical correctness and accuracy.
• Understands the theoretical basis of methods/experiments.
• Performs technical review of common laboratory data.
• Performs GMP review of solutions and wet chemical analyses.
• Performs technical review of typical laboratory data and HPLC analysis.
• Writes test procedures, protocols, and reports.
• Maintains laboratory stock of reagents, clean glassware, and removes expired solutions.
• Solves problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Assists in removal of hazardous waste, routine equipment cleaning and restocking of consumable products and reagents.
• Effectively uses various laboratory software packages (Empower3, ProCal, Master Control, ELN, etc.).
• Maintains a safe, clean, and organized work environment free of safety hazards.
• Safely handles potent compounds.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

• Masters degree in Chemistry, Biochemistry, or related field with 0+ years of related work experience.
• Bachelor's degree in Chemistry, Biochemistry, or a related field with course work in Chemistry with 4+ years related work experience.
• Or Associates degrees in Chemistry or related field with 10+ years related experience.

• Excellent verbal and written communication and documentation skills required.
• Strong detail orientation and organizational skills required.
• Strong problem-solving and basic trouble-shooting ability required.
• Strong knowledge of Laboratory equipment and safety required.
• Strong knowledge of Laboratory Documentation is required.
• Strong knowledge of cGMP in a pharmaceutical or regulated environment preferred.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

• Up to 5% travel required.

The physical demands and work environment 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. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk, sit, climb, or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, half face and full-face respirator, lab coats, full protective body coverings, various types of gloves, etc.