Quality Control

Scientist, Quality Control

Solaris Pharma Corporation is a leading specialty pharmaceutical company committed to identifying, developing and marketing of high-quality, complex, generic and specialty pharmaceutical products. With a thorough knowledge of the development life cycle and well-trained, committed scientific personnel, Solaris Pharma Corporation has streamlined processes that are efficient in reducing development costs and shortening timelines, without compromise in quality. We are dedicated to developing a broad portfolio of generic and specialty pharmaceutical products and providing early access to complex generic products for patients. Our pipeline which encompasses products from multiple dosage forms include but are not limited to sterile, dermatological, tablet products among others which are challenging to develop and manufacture with complexities arising from formulation & process development, regulatory hurdles, stability and scale up.

Solaris Pharma Corporation is currently developing several topical, sterile and tablet products, which are in different stages of development. The company has a dedicated team of committed and well-trained scientists along with experienced program managers and regulatory personnel who provide a robust product development process. The entire end-to-end product development process has been validated through multiple product approvals. A robust commercial infrastructure is in place to market our approved products. The commercial team has reinforced our success with timely product approvals by successfully launching multiple products under the Solaris label onto the market. Solaris has established an excellent reputation for being a dependable supplier with greater than 99% approval rating. The dosage forms that are being developed at our facility include: Topicals, Solutions, Suspensions, Ophthalmic and other sterile products and Tablets.

Description:

Solaris Pharma Corporation is seeking a Scientist, Quality Control with 3-5 years’ experience within the pharmaceutical industry.

Responsibilities:

• Performs chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA/ Karl Fischer, IR, TLC, pH meter, identification by XRPD, and chromatographic techniques, adhering to company policies as identified in standard operating procedures (SOPs).
• Must be able to follow compendial (USP/EP/BP/JP) procedures/ in-house (SOPs) with limited supervision. Comply with cGMPs, SOPs, and STPs to avoid an out-of-specification situation. Assure compliance with state and federal regulations.
• Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analysis. Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
• Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required.
• Review laboratory analysis data for completeness, specification compliance, with company’s written policies.
• Actively participates in and leads any abnormal findings/ investigation of out-of-specification laboratory results with Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications.
• Responsible for executing analytical method validation // method transfer activities.
• Ensures that expired chemicals and reference standards are removed from the laboratory area, perform calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, GC, and other laboratory instruments assigned by the supervisor.

Experience:

• Familiarity with GLP/GMP guidelines.
• Familiarity with out-of-specification (OOS) and out-of-trend (OOT) investigation.
• Computer literate.

Requirements:

• Bachelor’s degree in chemistry, Biology, Materials Science.
• Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
• Must be detail oriented.
• Demonstrate ability to explain complex concepts with clarity and simplicity
• Assists, as and when needed, senior scientists working in the laboratory.