Job description

ABOUT US
Pine Pharmaceuticals is a family-owned and operated pharmaceutical company located in Tonawanda, NY along the beautiful Niagara River in the scenic Riverwalk business park. Our team is growing dramatically to meet the tremendous demand for sterile compounded drugs used by physicians every day across the country. Driven by teamwork, Pine is a prominent leader in the 503B outsourcing space, where we continue to innovate.

WHAT IT'S LIKE TO WORK HERE
Pine was founded on a culture of caring, and not just about the specialty coffees available on-campus! At Pine, our employees care about each other, about our community, and about the patient who will ultimately receive the drugs we are responsible for compounding every day. There are a lot of perks working for Pine, including regularly catered lunches, employee appreciation programs, generous discretionary bi-annual profit sharing, healthy work-life balance, and much more! Above all else, Pine Pharmaceuticals is a family-owned and operated company, and employees are treated just like that. Family!

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Job Summary: *
**This is a 2nd shift position! Shift is from 3p-11p M-F**
The MQA - Finished Product Quality department is responsible for the assurance that all finished compounded products meet cGMP requirements for approval and release.

Essential Responsibilities & Duties:

• Performance of the verification of visual inspection results for all batches, including:

• Review and approval/rejection of questionable units

• In-process review of operator findings during visual inspection and escalation as appropriate

• Post-batch calculation of defects and escalation/initiation of non-conformance investigations as appropriate

• AQL of visual inspection for all batches of finished product

• Subject matter experts for investigations relating to visual inspection, including video review as needed

• Escalation of visual inspection failures to Nonconformance events

• Performance as needed of downstream manufacturing quality checks, including:

• Bubble point/filter integrity testing

• Verification of volume remaining upon completion of batch manufacturing

• Completion of batch quality records and associated documentation review

• Label quality checks including:

• Verification of label content to ensure adherence with requirements

• Performance of label AQL to confirm accuracy of content

• Label issuance and reconciliation

• Escalation of label reconciliation failures to Nonconformance events

Other Responsibilities & Duties:
Interdepartmental collaboration on routine SOP review and process improvement.
Collaboration with Training Department for visual inspector qualification.
Routine observation of visual inspectors and auditing of technique to ensure compliance with cGMP and applicable internal policies/procedures.
Additional long term projects/process improvements as needed.

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Qualifications, Skills & Abilities Required: *

• Excellent time management skills

• Attention to detail

• Good documentation skills and practices

• Ability to adhere to standard operating procedures and policies

• Effective at communicating with others including providing corrections, coaching, and training as needed

• Able to work independently and as a team

• Flexibility based on demand/workload

Experience Required:

• One year minimum of working experience in cGMP environment, preferably in visual inspection and/or QA/QC functions

• Strong preference given to candidates with understanding of FDA cGMP, CFR Parts 210 and 211

Physical Requirements:

• Must be able to fulfill dynamic shift responsibilities, moving from one room to another with ease as workload demands change

• Work requires standing and sitting for extended periods of time

Benefits:

• 401K with company match
• Discretionary bi-annual profit sharing
• Health insurance (eligible to enroll on first day of hire)
• Generous vacation/sick time
• Paid holidays
• Positive work/life balance
• Peer recognition program
• Leadership development
• Employee discount at our sister company, Pine Pharmacy

Job Type: Full-time

Pay: $20.00 per hour

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