Job description

QA Compliance Specialist

$60,000 per year

Direct/Hire Permanent Position

Pharmaceutical Manufacturing

Miramar, FL

Job Summary

Follows investigation and audit procedures, participates in investigations (Internal as well as external) and routs associated files for approvals, reviews, and files applicable investigation document appropriately. Log all applicable investigations records and perform data entry in applicable reports and develop graphs of trend data.

Job Responsibilities

• Provides support during internal or external investigation performed on site.
• Supports the updating and managing of audit process and procedures.
• Initiates documentation associated with Investigation and CAPA records.
• Assign numbers to Investigation and CAPA records.
• Routes investigations for review, approval, and archiving.
• Track status of Investigation, CAPA, and follow-up with owners to assure timely actions and completion.
• Communicates closure of investigation and CAPAs to organization.
• Follow Investigation and CAPA procedures in order to monitor and trend investigation data.
• Log and data entry of Investigation and CAPA information.
• Develop and distribute Investigation and CAPA report on a weekly basis.
• Develop and distribute reports and graphs as requested for trending purposes.
• Experience developing reports and creating investigation files.
• Works as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• Other duties as assigned by the manager.

Job Requirements

Education

• Associate Degree in Science, Business Administration or Healthcare Administration with 3 years of experience, or high school diploma with 3 - 5 years of experience with cGMP, CAPA, investigation process and regulated pharmaceutical/medical device industry practices.

Knowledge, Skills and Abilities

• Strong knowledge of personal computer and databases such as MS Office, Word, Excel, and Power point.

• Experience Working with cGMP procedures in a Pharmaceutical and or Combination Device manufacturing facility.
• Experience managing investigation, CAPA process and writing Quality reports.
• Demonstrated ability of having cross functional / team experience.
• Communicates well.
• Demonstrated Technical writing skills.
• Ability to understand and follow operating procedures, in order to perform data entry and develop reports.
• Must be able to effectively present information and respond to questions from management and/or peers.
• Must be able to read, write, and speak English proficiently.
• Ability to read, creates, and interprets charts.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Experience

• Quality Assurance experience in the pharmaceutical or other regulated industry is required.

Job Type: Full-time

Pay: $55,000.00 - $60,000.00 per year

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Miramar, FL: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you have knowledge of 21CFR Part 211

Education:

• Associate (Required)

Experience:

• Pharmaceutical industry: 3 years (Required)
• Managing of audit process and procedures.: 3 years (Required)
• cGMP, CAPA, investigation process: 3 years (Required)
• writing Quality reports: 3 years (Preferred)

Work Location: One location

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