Position Title: QC Associate 1 - Raw Materials/Water
Work Location: Sanford, NC, 27330
Assignment Duration: 12 Months
Work Schedule: Not explicitly mentioned
Work Arrangement: On Premise

Position Summary:
Perform various chemical tests such as water analysis, FTIR, ID, HPLC, and other compendial assays.

Key Responsibilities:

• Write and perform raw material verification protocols and associated reports.

• Ensure training records are updated and correctly filed to reflect current testing capabilities.

• Perform sampling and labeling of materials as per defined procedures and verify all equipment and instruments.

• Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.

• Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.

• Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.

• Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database.

• Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.

• Perform tasks associated with maintaining Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories.

• Support environmental monitoring/water testing in the QC Raw materials laboratory.

• Test incoming raw materials per compendial methods.

• Follow Environment Health and Safety requirements for site and QC laboratories.

• Support product transfers, new product development, regulatory queries, cost improvement projects, and Drug Product plant support for Cleaning Validation.

• Operate within established HR policies and basic colleague relations guidelines.

• Write Standard Operating Procedures (SOPs), technical reports, project plans, etc.

Qualification & Experience:

• Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience.

• Demonstrated technical skills in chemistry laboratory testing.

• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations.

• Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.

• Excellent organizational skills and strong ability to multi-task.

• Strong written and verbal communication skills.

• Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation.

Bonus Points If You Have (Preferred Requirements):

• Experience with laboratory work, particularly using analytical techniques such as HPLC, pH, Polarimetry, etc.

• Proven track record in leading continuous improvement projects.

• Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis.

• Strong problem-solving skills and attention to detail.

• Ability to manage multiple priorities and meet deadlines.

• Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels.

• Adaptability and willingness to learn new techniques and procedure.

Physical/Mental Requirements:

• Non-existent to minimal travel.

• Must be able to wear appropriate PPE (e.g., lab coat, safety glasses, non-porous shoes, gloves, etc.).

• Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.

• Intellectual capability to perform complex mathematical problems and perform complex data analysis.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 35.08/hr.