Quality Assurance Specialist at Merck Group

Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-POKQB Cherokee Quality Assurance 2
Recruiter: Guadalupe Barragan

This information is for internals only. Please do not share outside of the organization.

Your Role:

This individual will work various internal departments to improve and execute processes in compliance with cGMP regulations in 21CFR 210, 211, Part 11 and in ICH Q7. Duties in this role will include:

• Main job responsibilities will be review and approval of deviation, OOS and OOT investigations.
• Administer daily and weekly deviation status meetings.
• Maintain monthly deviations trending.
• Write, review, and approve CAPAs and Change Controls.
• Participate in internal/external audits as needed.
• Provide quality oversight and support for new product introductions as primary quality point of contact.
• Respond to quality-related customer questions.
• Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols, and other controlled documents under a Quality Managed System (QMS).
• Review batch records for completeness and accuracy based on GMP requirements to ensure acceptable product and process consistency.
• Interact with production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
• Monitor for quality related issues and collaborate on resolution as quality on the floor.
• Lead Process Improvement for Quality related initiatives/projects.

Physical Attributes:

Environmental conditions will vary depending on specific job responsibilities; typically, 70-90% Office Environment, 10-30% Production, QC, Packaging.

Who You Are

Minimum Qualifications:

• Bachelor's Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) or other Life Science discipline
• 5+ years QA and/or QC experience.

OR

• Master's Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) or other Life Science discipline
• 2+ years QA and/or QC experience.

Preferred Qualifications:

• Knowledge of ICHQ7 and API knowledge &/or experience.
• TrackWise and SAP experience.
• Proficiency in MS Word, MS Excel, MS PowerPoint and ability to learn and operate using other specific application software.
• Excellent communication (verbal & written) and customer interface skills.
• Excellent writing skills and experience writing technical documentation & reports.
• Ability to simultaneously manage multiple tasks/priorities.
• Good problem-solving skills/abilities.
• Good time management and negotiating skills.
• Capacity for independent work.
• Data analysis, presentation, and experimental design knowledge.

RSREMD

Pay Range for this position: $65,800-$105,200.00

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.