QA Operation Specialist (Biopharma)

THIS ROLE WILL REQUIRE Wisconsin RELOCATION

This Permanent Full-Time Position offers fantastic working culture, and an exceptionally competitive compensation package.

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Biopharma QA Operation Specialist

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Our team at PharmAllies has teamed up with a mid-sized pharmaceutical manufacturing firm to supply them with exceptional personnel (Full-Time Permanent Positions). This company has the experience, expertise, and a successful track record in delivering life-changing products and medical devices. Together with their clients, they treat many forms of cancers, diabetes, infectious diseases, and many other illnesses. Your work will matter, and your contributions will be significant in these endeavors. So make a difference, apply today!

JOB SUMMARY

The Senior QA Specialist - Operations reviews all records associated with manufacturing a product lot for completeness and accuracy to ensure qualified specifications, parameters, and controls have been met and/or all deviations from such have been adequately and timely addressed.

JOB RESPONSIBILITIES

Complete Executed Batch Record/protocol Review and supporting documentation independently:

• All Deviations & supporting documentation
• Quality Control records
• Data environmental Monitoring

• CAPA documents and QA investigations
• Cleaning / Sterilization cycle records and testing
• Review protocol, study design, and Master batch Records independently
• Responsible for writing and revising Standard Operating Procedures, material control procedures, deviations, CAPA's, and Quality Investigations when applicable independently
• Create / Revise documents using MS Office
• Review/approve minor/major/critical system SOP updates
• Retrieve GMP Records upon request
• Assist and/or confirm with Line Clearance
• Complete AQL Sampling and Inspection of Final Package Lots as applicable
• Lead teams to modify QA systems independently and report recommendations to QA management.
• Provide ideas for QA improvements to management and independently implement once approved
• Obtain gown certification for aseptic operations if the position is at an aseptic facility
• Other duties as assigned

EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE

• Exceptional organizational skills
• Detail-oriented
• Ability to multi-task
• Word Processing, XL spreadsheets, SOP generation
• Competent in MS Office
• Professional verbal and written communication skills required
• High School diploma with 20 years experience in GMP QA environment; Bachelor of Science Degree preferred with 15 years (Master's degree 10 years) in QA in a cGMP environment

PHYSICAL REQUIREMENTS

• Ability to read, understand, follow and comply with technical and written documents (SOPs) written in English
• Requires the ability to communicate effectively using speech, vision, hearing, and written word
• Must be able to sit or stand for long periods of time
• Ability to gown and work in an ISO-5 environment preferre
• Interacts with all departmental staff, including giving training and/or presentations to large groups

The above statements describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

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Job Type: Full-time

Pay: From $1.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• 8 hour shift

Supplemental Pay:

• Bonus pay

Application Question(s):

• Will you now, or in the future require our company to commence (sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)?
• Will you be able to commute or relocate to Wisconsin for this job?

Education:

• Bachelor's (Required)

Experience:

• Pharmaceutical: 10 years (Required)
• Biopharmaceutical: 10 years (Preferred)

Work Location: One location