Quality Assurance Specialist (QA for QC)

Role Summary

Quality Assurance Specialist (QA for QC) provides QA oversight for the Quality Control (QC) Department. This role reviews and approves quality method validation, QC equipment qualification, QC protocols, reports, QC process control documents, new and existing procedures, and QC deviation investigations. The individual acts independently to support process improvement and facilitates implementation.

Responsibilities

• Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol, Technical documents, amongst others.
• Provide final QA approval on change control, compendial assessments, and other documents associated with the business unit.
• May also review and approve documents such as Deviation, contract laboratory investigation, and Non-conformance investigations associated to Protocol executions.
• Capable to make quality decisions in real time according to regulations and procedures.
• Ability to work collaboratively with internal partners to resolve technical issues.
• Willing to perform other duties as assigned and take ownership to support the implementation of activities needed to support the business needs.

Qualifications

• Required: Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an Associate’s degree with 4 years of experience OR a Bachelor’s degree in Science or related field with 0 years of experience.
• Required: Ability to be problem-solving and analytical skills.
• Required: Knowledge of Pharmacopeia, Familiarize with Equipment Qualification and Regulatory Requirements.
• Required: Attention to detail and the ability to work independently.
• Required: Experience in Quality Control Laboratory cGMP’s Laboratory environment.
• Required: Experience or background of applied statistics.
• Required: Proven ability to work in a team environment through conflict resolution and negotiation.
• Required: Provides excellent communication, writing, and analytical skills.
• Preferred: Experience in manufacturing, laboratory, quality, technical or engineering experience within biotech or the pharmaceutical industry; preferred experience in Quality Control Laboratory.
• Preferred: Familiarized and experienced in Pharmacopeia requirements (e.g., USP, JP, EMEA).
• Preferred: Familiarization with the Data Integrity requirements.
• Preferred: Experience with deviations, Change Controls, Stability Protocols, and related implementation activities; support in CAPA closures, effectiveness checks, and root cause analysis tools.
• Preferred: Experience in a quality assurance role, preferably in QA for Quality Control documentation (e.g., OOS, OOE, OOT investigations, specifications, method transfer protocol, stability protocol, and related items).

Education

• High School Diploma (or Equivalent) with 6 years of relevant experience; Associate’s degree with 4 years; or Bachelor’s degree in Science or related field with 0 years of experience.

Additional Requirements

• Physical / Mental Requirements: Ability to work in a fast-paced, dynamic environment.
• 50% on the floor time (walking/standing).
• Able to manage different priorities.
• Occasionally lift and move objects up to 30 pounds.
• Stand/walk during the entire length of the shift.
• Visual abilities including near and far sight, color, peripheral vision, depth, and ability to focus.
• Gowning is a requirement of this position as is the use of PPE (Personal Protective Equipment).
• Regular business hours or shift schedule.