Pharmaceutical - Senior QA Specialist

THIS ROLE WILL REQUIRE MASSACHUSETTS RELOCATION

Permanent Full-Time Position

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Senior QA Specialist

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Our team at PharmAllies has teamed up with a mid-sized biopharma manufacturing firm to supply them with the personnel (Full-Time Permanent Positions) needed for critical COVID vaccine manufacturing efforts. This company, on the forefront of producing lifesaving vaccines, values the diversity each employee brings to their role and their contributions to helping them achieve their mission?to protect and enhance life. They also value talent, develop employees and offer opportunities to advance their staff so that they can achieve personal and professional growth. If you want to make a worldwide health impact, take a look at our available positions and apply today!

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JOB SUMMARY

The QA Specialist II professional will be responsible for managing the quality Batch Record Review process to ensure timely completion of review, approval and closure, training of team members and management of quality binders. Responsible for Product and Raw Material Disposition process, to include coordination with QC for product specifications test results, coordination with Fill Finish site quality, 3rd party Diluent supplier and Supply Chain. In addition, the QA Specialist II will support the manager with the Complaint and APR programs at the company site, manage the Right First Time (RFT) metrics, provide On-the-Floor support to manufacturing and a quality SME of SAP material master data. Manage and lead projects, own quality records (Deviation/CAPA/Change Control) and support additional work as required.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Review/Approve of Batch Records (including APS, Engineering and Development runs) and other related documentation.
• Disposition of Product and Raw Materials & components. Quality SME in SAP Master Data
• Manufacturing On-the-Floor support (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.)
• Provide data for functional area metrics for APR and complaints among others with the objective to identify and improve system compliance and/or process challenges
• SOP generation, review and/or approval
• Own quality records (Deviation/CAPA/Change Control).
• Manage and support the Complaint program
• APR generation and approval
• Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals
• Lead or assist in continuous improvement projects as assigned interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross-functional peers across Emergent to gain alignment on sound quality decisions.
• Lead and support additional work as required.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelor’s Degree in Scientific or related fields
• A minimum of seven (7) years of cGMP Quality experience
• Product and Raw material disposition is a must
• Well versed in SAP is a must
• Batch Record review is a must
• Strong Commercial manufacturing experience (Large Molecules) required
• Expertise on change control, complaint management and Annual Product Review/Product Quality Review (APR/PQR) is a must
• Experienced with US, EU pharmaceutical regulations, and ISO standards
• Expert Knowledge and application of GMP principles
• Excellent communication skills: oral, written and listening
• Ability to influence without authority across cross-functional organization

Job Type: Full-time

Pay: $0.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Experience:

• Biopharma: 5 years (Preferred)
• Batch Record Review: 5 years (Preferred)

Work Location:

• One location

Company's website:

• www.PharmAllies.com

Work Remotely:

• No

COVID-19 Precaution(s):

• Remote interview process
• Social distancing guidelines in place