Quality Control Analyst I

About the Role

This position is responsible for performing testing and analysis of incoming materials, intermediates, finished products, swab samples, and other samples to support the commercial and development activities at the site in compliance with all regulatory requirements, company policies, and procedures.

Responsibilities

• Test and analyze incoming materials such as intermediates, finished products, and swab samples.
• Prepare, maintain, and review thorough records and documentation on solutions, sample preparation, and investigational/experimental samples.
• Support laboratory investigations into Out of Specification/Out of Trend results or other laboratory events.
• Perform revisions to documentation such as Standard Operating Procedures, Test Methods, and Specifications.
• Coordinate and send materials for contract laboratory testing.
• Ensure compliance with DEA and site requirements regarding the handling, use, and disposal of controlled substances.
• Perform verification of compendial methods.
• Provide training to other analysts on activities for which you have developed expertise.
• Perform peer review on documents, which may also become a full-time role.
• Assist with activities associated with the stability program, including sampling and statistical analyses.
• Assist with sampling of incoming materials as needed.
• Maintain work areas and perform job functions in a safe and efficient manner in accordance with company policies, Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and Batch Record instructions.
• Perform additional related duties as assigned.

Requirements

• Bachelor’s degree, preferably in Chemistry or Microbiology, or equivalent education/experience with a minimum of 3 years of relevant progressive experience in a Quality Control Laboratory environment.
• Solid understanding of the principles of analytical chemistry as it applies to HPLC, GC, FTIR, UV-Vis, and other general analytical techniques.
• Working knowledge of cGMP, DEA, and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Experience with Laboratory Information Management Systems (Labware LIMS and/or Empower preferred).

Skills

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle, and manufacturing/quality systems such as LIMS, Trackwise, and Qdocs.
• Ability to effectively document processes and explain scientific/technical ideas in writing (technical writing skills).
• Excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management, and other internal stakeholders.
• Self-directed with the ability to organize and prioritize work.
• Detail-oriented with the ability to identify errors and/or inconsistencies while performing tasks.
• Problem-solving skills to work on problems of moderate scope where evaluation of contributing factors requires analysis of situation or data.
• Ability to exercise judgment within broadly defined practices and policies and select methods and techniques for obtaining solutions.
• Acts independently and proactively to recommend methods and procedures for problem resolution.

Working Environment

• Exposure to fumes, odors, dusts, mists, or gasses (for non-office roles).
• Exposure to moving mechanical parts or moving equipment.
• Exposure to low to moderate to loud noise levels.
• May be required to wear personal protective equipment (PPE) as needed for assigned area and/or process (e.g., safety glasses, gloves, hearing protection).

Benefits

• Comprehensive health insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment.
• Retirement savings: 401(k) with employer match up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Paid Time Off including vacation, sick/safe time, caretaker time, and holidays.
• Company-paid Life and Disability insurance.
• Employee Assistance Program.
• Employee Stock Purchase Plan.
• Tuition Assistance.
• Flexible Spending Accounts and Health Savings Account.
• Lifestyle Spending Account.
• Volunteer Time Off.
• Paid Parental Leave (if eligible).
• Family Building Benefits.
• Virtual Physical Therapy.
• Accident, Critical Illness, and Hospital Indemnity Insurances.
• Identity Theft Protection and Legal Plan.
• Voluntary Life Insurance and Long-Term Disability.