What are the responsibilities and job description for the Quality Control Analyst II position at Piramal Enterprises?
This position is 2nd shift hours.
The QC Analyst II performs Analytical chemistry examination testing on raw materials, finished products or stability samples in accordance with approved Standard Operating Procedures (SOPs) and valid methods. This is a safety-sensitive position.
Key Responsibilities
- Chemical or Physical testing analysis of raw materials, finished products, stability or request samples
- Documenting and submitting all raw data and results in LIMS
- Preparation of reagents for chemical analysis including peer review
- Knowledgeable in compendial (USP/EU) testing requirements and ensuring compliance per FDA 21 CFR
Competencies
- Good understanding of laboratory safety practices and PPE. Expectation of zero safety observations
- Good understanding of cGMP. Minimal to no laboratory errors are expected.
- Good understanding of good documentation practices. Minimal corrections/errors expected.
- Good understanding of compendial testing requirements. Additional understanding of international compendiums such as EP
- Expected to train other analysts. Minimal supervision necessary from management.
- Expected knowledge of balance, FTIR, dissolution, UV-VIS, Karl Fischer, pH, wet chemistry techniques, reagent preparation, volumetric solutions, able to handle independent HPLC testing such as cleaning validation, Assay, Blend Uniformity, Impurity Analysis, Dissolution, Content Uniformity.
- Able to perform assigned task from start to finish independently without error. Including standard, sample, and reagent preparation through data processing and submission.
Experience
- Bachelor's degree in chemistry, biology, microbiology or other related science with relevant laboratory coursework is required.
- 2 years laboratory experience, preferably in a GMP environment
- Wet Chemistry testing, Balance, Dissolution, FTIR, KFM, UV/Vis, Titrations, Viscosity, PSD testing, pH, conductivity
Competencies
- Strong written, verbal, and interpersonal communication skills
- Proficiency with computer software such as MS Word, Excel, or PowerPoint
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
