Sr. Associate Quality Control Raw Materials

The Sr. QC Raw Materials Associate is responsible for developing and maintaining quality systems for the Raw Materials department. Establishes departmental objectives in alignment will business and compliance needs. Manages systems and procedures to protect departmental assets. This position is responsible for QC sampling, testing and release of incoming raw materials, components, and biological materials used in the production process per established procedures. The role will also support oversight and review of contract testing of raw materials. Demonstrated experience in developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives.

Wacker is a safety-first organization, and this position will also be critical in maintaining a safe work environment.

Essential Functions:

• Oversight of the Raw Materials Program, performing analytical testing following established protocols, review of raw material data, and investigations. Coordination and scheduling the raw materials testing activities and managing/trending raw materials data to meet manufacturing timelines.
• Ensures adherence to defined internal controls. Manages systems and procedures to protect departmental assets. Responsible for developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives.
• Oversight of assay verification, qualification, validation, and tech transfer activities. Verification of maintenance, calibration, and qualification of laboratory equipment. Assist in troubleshooting equipment malfunctions, assay system suitability failures, assay deviations, CAPAs, and out of specifications investigations. Coordinate instrument preventive maintenance and validation activities.
• Authoring and reviewing Quality Control Standard Operating Procedures (SOPs), Assay Qualification/Verification Protocols and Reports to implement new raw material release assays.
• Under the guidance and in collaboration of the Head of Quality Control, create organizational objectives and establishes departmental goals.

Position Qualifications:

• Bachelor of Science Degree in the Chemistry, Biochemistry or Biological Sciences with a combination of education and experience performing chemistry, biochemistry, and biology. Master's degree preferred.
• A minimum of 6 years of experience performing quality control activities in the pharmaceutical and biotech industry under GMP guidelines, with a demonstrated expertise in multiple disciplines, assays, fields.
• Ability to travel up to 5%
• Experience in the development and establishment of operations of QC laboratories in a GMP regulated environment.
• In-depth experience related to non-compendial method development, optimization, and validation, as well as compendial method verification.
• Demonstrated ability to work independently on projects, and review project data and provide summary analysis reports based upon the data.
• Ability to provide support for regulatory and client audits, as well as interact with clients.
• A profound understanding of analytical instrument principals and application of advance instrumentation analysis for raw materials release in a pharmaceutical/biotech setting. (FTIR, GC, HPLC, MS, Karl Fischer, Titrators)
• Strong knowledge of pharmacopeia (USP, EP, JP) monographs/testing methodologies and regulatory requirements (ICH, FDA, EMA) as is relates to raw materials in the pharmaceutical industry. (GDP, cGMP and quality systems including OOS investigations, deviations and CAPAs)
• Analysis and comparison of data to historical trends and applicable product specifications to ensure consistent materials are used in the manufacturing process.
• Experience working with different contract laboratories in support raw materials release testing.
• Understanding and familiar with use(s) of various pieces of Materials Handling equipment.
• Sets stretch goals and links them to strategic outcomes and business deliverables
• Exercises sound judgement within defined procedures and policies to determine appropriate action
• Strong scientific, analytical, and problem-solving skills as well as sound judgement, to identify problems and leads efforts to resolve them.
• Ability to be self-motivated, proactive, accountable, and flexible.
• Ability to work well under pressure, handle multiple tasks/projects and meet deadlines.
• High attention to detail, highly organized, and excellent documentation skills.Strong communication skills, both written and verbal in the English language, and outstanding interpersonal skills are essential job requirements.
• Accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.
• Knowledgeable using Microsoft Office as well as developing any documentation and creating tables for laboratory inventory and data entry.
• Ability or capable of lifting up to fifty (50) lbs.

The anticipated salary range for candidates who will work in California is $111,000.00-130,000.00. The final salary offered to a successful candidate 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, education, etc. Wacker is a multi-state employer, and this salary range may not reflect positions that work in other states.

• 
  
  Compensation and Incentive plans
  
  
• 
  
  Medical, Dental, and Vision Insurance effective day 1
  
  
• 
  
  Paid Time Off in addition to personal days and holidays
  
  
• 
  
  Paid parental leave
  
  
• 
  
  Wellbeing fund
  
  
• 
  
  Flexible hybrid work arrangements
  
  
• 
  
  401(k) with company match
  
  
• 
  
  Education Assistance Program
  
  
• 
  
  Career development and advancement opportunities
  
  
• 
  
  Support for Community Involvement