QC Chemist who is responsible for performing quality sampling, aliquoting, shipping, testing and data review for raw materials under cGMP conditions. The role will support the manufacturing campaigns by ensuring raw materials testing completion within established timelines. The role will also support operation and maintenance of QC laboratory equipment/instrument to comply with cGMP regulations.
- Conducts and documents routine compendial (NF/USP/BP/EP/JP) and non-compendial raw material testing, in cGMP environment to support manufacturing.
- Serves as a qualified trainer with appropriate experience in performing routine raw material testing, trains other team members.
- Able to receive and process raw materials using SAP to assign testing requirements and ensure chain of custody of materials within the laboratory.
- Able to seek additional tasks (aliquoting, sample shipments, laboratory inventory, reviews and approves routine compendial test results documents and other laboratory tasks) or non-routine functions and accomplish them according to written procedures in compliance with cGMP with general supervision. Overcomes minor conflicts with priorities. Consults supervisor with major conflicts of priorities.
- Performs laboratory duties and safety checks following all safety, cGMP, CFR and other regulations to assure laboratory compliance. As assigned, participates in EHS team for Chemical Inventory, Risk Assessments or other initiatives as assigned by management to ensure laboratory compliance.
- Work with the manager to conduct laboratory investigations, deviations and change controls related to raw material testing; Able to use SAP to manage notifications on-site (DE/LI/MC/CAPA) by adhering to timelines.
- Evaluate laboratory SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines. Develop or revises laboratory SOPs as required.
- Able to work effectively as part of a team and exhibit effective interpersonal skills within the group as well as with other groups within the department.
- Trained as an L1 Auditor and participate in >25% of department's L1 Inspections. Maintain the laboratory according to EHS requirements. Participate in continuous improvement programs such as GPS, ZAPs, ZIPs.
- Participates in the on-call response team for chamber maintenance or ADHOC raw material testing.
Required
- Level of Education B.S. / B.A. degree in science field is required.
- 3+ years of relevant experiences in a pharmaceutical development or quality control environment. 1+ year of compendial testing experience. 2+ year of cGMP laboratory experience.
Preferred
- Area of Specialization Chemistry is preferred
The anticipated salary range for this position in Maryland is $83,325 to $110,100 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
Benefits:
• 13 paid holidays
• Vacation time
• 401K match
• Medical, dental and vision benefits effective day one of employment
